chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 19:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: tested negative for 2-3 days on antigen tests post paxlovid course; (Mar2023) Negative, notes: tested negative for 2-3 days on antigen tests post paxlovid course; (Mar2023) Negative, notes: tested negative for 2-3 days on antigen tests post paxlovid course; (17Mar2023) Positive; (20Mar2023) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Injection site became swollen, red, bruised, and warm to the touch. It continued to get worse for 36 hours and then started healing in the third day.
On the morning after the second vaccine, I awoke with a bad headache. I was expecting something like this so I didn't worry about it.  Within a couple of hours, however, the headache began to include migraine-like visual disturbances primarily in the left eye field of vision.  The pain got worse.  I took Tylenol as I was advised not to take ibuprofen.  The headaches and visual disturbances continued intermittently for a couple of weeks.  (The headaches are still here at a low level.  The visual disturbances/flashes disappeared after 12 days.)  While I was having the migraine-like symptoms, after about two or three days, I developed additional visual problems in my left eye.  There was like a gray nebula of strands in my visual field.  I went to the ophthalmologist on 4/6/21, 10 days after the shot.  She diagnosed Posterior Vitreous Detachment (PVD).  While she knew of no mechanism for the vaccine to cause this, I am reporting this as the headaches, visual disturbances/flashes, and the PVD developed immediately after the second Pfizer shot, headache rolling into flashes rolling into PVD nebula.  The doc said this may or may not go away after a while.  We shall see.
Both vaccine in upper left arm. After 48 hours Lt. arm very swollen (no pain) twice size of Rt. arm. Pharmacist informed. Recommended frequent hot Epsom salts compresses. No improvement, telephoned minor injuries at hospital. Discontinue compresses, apply ace bandage - this on 4th day. 6th day saw Dr. Cephalexin 250mg 3 x a day for 10 days. 22nd day - Lt arm improved but still noticeably larger than Rt. arm. Swells up during the day.
Day of vaccine I had intense throbbing in my armpit. Two days later I realized it was swollen to the size of a tennis ball. My whole upper arm was swollen as well.  The swelling is slowly going down and the pain is gone.
One week after vaccine my arm below the injection site broke out in a circular  bumpy red rash that itches.
First two doses administered were Pfizer but today the patient received a Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (First two doses administered were Pfizer but today the patient received a Moderna vaccine) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (First two doses.).    On 28-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (First two doses administered were Pfizer but today the patient received a Moderna vaccine). On 28-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (First two doses administered were Pfizer but today the patient received a Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.
Lip, mouth, and togue swelling within 20 minutes of injection lasting 48 hours. Moderate to sever itching setting in 24 hours after injection and lasting more than 3 days. Itching and pain and injection site setting in after 24 hours lasting 3 weeks. No period in month following injection with no issues before this.
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received BOOSTRIX (batch number B54KE, expiry date 2nd April 2017). This case was associated with a product complaint. On 8th June 2015, the patient received the 1st dose of BOOSTRIX .5 ml. On 9th June 2015, 1 days after receiving BOOSTRIX, the patient experienced injection site pain and injection site swelling. On an unknown date, the patient experienced product complaint. On an unknown date, the outcome of the injection site pain, injection site swelling and product complaint were unknown. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to BOOSTRIX. Additional information provided: The physician suspected a Quality Concern with this vaccine and their office has withheld the rest of this lot number. QA filed UV20150062. This case is one of the 2 cases reported by the same reporter for the same vaccine. QA Results (Complaint number UV20150062) received on 07 July 2015: the review of the safety data reported for batch number B54KE and other associated batches does not highlight a safety issue. It is unlikely that the reported events are related to a product quality issue from manufacturing origin. No investigation is required.
This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient concomitant therapies included an unspecified blood pressure (hypertension) and unspecified eye drop medications. The patient had no drug reactions or allergies. On 10-NOV-2017, the patient was vaccinated with ZOSTAVAX (lot # N021170, expiration date 27-OCT-2018) (route of administration and frequency were not reported) in the left arm for prophylaxis diluted with sterile diluent (MERCK STERILE DILUENT). On an unspecified date in November 2017 after receiving ZOSTAVAX, the patient developed a rash at injection site on left arm (injection site rash). The pharmacist instructed her to medicate with diphenhydramine hydrochloride (BENADRYL) and ice. It was reported that no intervention to prevent serious criteria was necessary, that the patient was not hospitalized, and that the patient experience was not significant disability or incapacity or life threatening. At the time of the report, the outcome of injection site rash was reported as not recovered. The relatedness assessment between ZOSTAVAX and injection site rash was not provided.
Began about 20 hours after, lasted 18-20 hours. Fever of 102, shivers, aches, fatigue. Treated with extra sleep (nap; unusual) and fluids
sore arm day 1 headache started on 1/7 and have progressively gotten worse.   1/20 did virtual visit with PCP and was started on Flexeril and 800mg motrin.  No relief from either.  Stopped Motrin 1/22 and was prescribed Prednisone 30mg x 3 days, 20mg x 3 days and 10mg x 3 days.  Headaches have become almost constant at this point.
Report 20010042091 describes pain in the shoulders and neck of a 47 year old female who received an injection of hepatitis B vaccine (Engerix-B). Concurrent medical conditions and medications were not specified. The pt received her first injection of Engerix-B vaccine on 01/25/2001. "A couple of days later" (exact date not provided), she experienced pain and stiffness across the back of her neck to the base of her skull, then both sides of her neck. The pain and stiffness persisted as of 02/16/2001. The pt planned to be evaluated by her physician.
Patient received vaccine at a clinic sponsored by clinic. Patient is under 18 years of age and was not eligible for vaccine.
pt. complain of tingling and numbness of the lip.  She also c/o of light headache.  Symptom was resolved and pt. went home after light comfort measures.
Fever after flu vaccine to 101.0 chills, body aches, headache.
Patient received PENTACEL/HBV/PREVNAR 5/19/10. Mom says about 10 d after receiving vaccines her (R) eye was turning in. By 5/30/10 her eye was fixed in that position. Patient returned to clinic 6/3/10 and referred to ER. She subsequently saw an ophthalmologist who diagnosed 6th nerve palsy. No CT done. Recovered spontaneously in 4 wk.
shivering; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2019, the patient received the 1st dose of Shingrix. On 23rd September 2019, less than a day after receiving Shingrix, the patient experienced shivering and influenza-like symptoms. On 26th September 2019, the outcome of the shivering and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the shivering and influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced shivering and flu like symptoms.
we have a patient who was completely vaccinated but showing Covid symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (we have a patient who was completely vaccinated but showing Covid symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (we have a patient who was completely vaccinated but showing Covid symptoms). At the time of the report, COVID-19 (we have a patient who was completely vaccinated but showing Covid symptoms) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.
My son received the flu vaccine about 9:30 am on 9/1. A little less than 24 hours later on 9/2 at 7am my son complained of pain and warm to the touch arm. I saw lots of swelling, a hard bump, hot to the touch, redness in a large area of his arm. I gave Motrin. It appeared to help but wore off about 6 hours later and it got bigger and more uncomfortable. I picked him up early from school because teacher reported it getting worse.  As of today 9/4 there is still redness and warmth. It looks like it is improving but still hot to the touch.
pain in the arm that he received the injection in; This is a spontaneous report from a contactable consumer (patient's wife). A 95-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm on 13Feb2021 (Batch/Lot number was not reported) as second dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that on an unspecified date in 2021, the patient was still complaining of pain in the arm that he received the injection in. Outcome of event was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
One week after, fever for 4 days, stayed around 101. After fever a rash all over stomach chest and face appeared and lasted for 3 days
Patient's daughter reports a red, warm to the touch, area around vaccination site. States it is about 4 inches wide. States it is not painful or itchy.
This spontaneous report as received from a registered nurse refers to a 5 patient of unknown age and gender. On an unknown date the patients were vaccinated with ROTATEQ (orally, dosage was not reported) lot # H017722 exp date 09-APR-2014. Vaccines were improperly stored for a period from 20-MAR-2014 to 07-MAY-2014. Nurse stated vaccines were exposed to 10.5C for 56.05 hours cumulatively through 07-MAY-2014. No adverse effects reported. It was reported that the nurse was inquiring about temperature excursions that occurred from October 2013 to March 2014. The nurse also stated that they were replacing the refrigerator, freezer, and the data logger and were sending the old data logger for calibration to the health department. The reporter stated that vaccines were improperly stored for a period from 28-AUG-2013 until June 2014 and were received by 5 patients (previously reported from 20-MAR-2014 to 07-MAY-2014). Highest temperature: 9C: number of hours prior to administration: 35H; number of doses administered 1. Highest temperature: 9.5C; number os hours prior to administration: 206H; number of doses administered: 1. Highest temperature: 9.5C; number of hours prior to administration 269H; number of doses administered: 1. Highest temperature: 10C; number of hours prior to administration: 271H; number of doses administered: 1. Highest temperature: 10C; number of hours prior to administration: 277H; number of doses administered: 1. All doses administered before expiration date. This is one of the several report from the same source. Additional information has been requested.
severe bilateral eye pain, severe joint/muscle pain beginning about 6 hours post vaccine, orthostatic hypotension, +subjective fever
Initial unsolicited report received from a pharmacist on 14 October 2016. This case involves a 57 years old male patient who was vaccinated with a dose of FLUZONE (batch number, expiry date, dose, dose in series were not reported) via intramuscularly route at left deltoid on 03 October 2016. The patient's medical history reported as unknown Concomitant medications were not reported. On 05 October 2016, two day following the vaccination, the patient felt like there was a spider walking, running around on his arm half inch from the injection site. It felt like the spider was down near his wrist also The patient's laboratory data and corrective treatment was not reported. THe outcome of event was reported as not recovered. List of documents held by sender: none.
Dizziness; Migraine; Headache; Extreme fatigue; Body aches; Chills; vaccination site swelling; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), MIGRAINE (Migraine), HEADACHE (Headache), FATIGUE (Extreme fatigue) and MYALGIA (Body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced DIZZINESS (Dizziness), MIGRAINE (Migraine), HEADACHE (Headache), FATIGUE (Extreme fatigue), MYALGIA (Body aches), CHILLS (Chills) and VACCINATION SITE SWELLING (vaccination site swelling). At the time of the report, DIZZINESS (Dizziness), MIGRAINE (Migraine), HEADACHE (Headache), FATIGUE (Extreme fatigue), MYALGIA (Body aches), CHILLS (Chills) and VACCINATION SITE SWELLING (vaccination site swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided.   Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded   Reporter did not allow further contact; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Developed tinnitus in right ear.  Noise level varies, from soft to fairly loud, but is constantly present.
Information has been received from a 75 year old female consumer with hypertension, who was also the patient, who on 05-MAR-2009 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included unspecified blood pressure medication (also reported as no concomitant medication). On approximately 12-MAR-2009, "about 1 week after vaccination", the patient experienced a rise in blood pressure. The patient had seen her doctor and her blood pressure medication had been increased. Her blood pressure was as high as 190/99. At the time of this report, the patient's symptoms persisted. The consumer also reported that her husband experienced a rise in blood pressure after vaccinated with ZOSTAVAX (Merck) (WAES # 0903USA05479). Additional information has been requested.
This spontaneous report as received from a pharmacist refers to several female patients of unknown age. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies were provided. On an unknown date, it was reported that the patients were vaccinated with PNEUMOVAX 23 (lot number, expiration date, route of administration and dose were not provided) for prophylaxis. On an unknown date, several women experienced rash after vaccination with PNEUMOVAX 23. The outcome of the events and relatedness between the event rash and the PNEUMOVAX 23 were not provided. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1810USA000461.
TD placed 4/12/10. Sore at site x 2 days. Then increased with redness, warmth, itching and swelling of left upper extremity. Placed on antibiotic with relief of sxs.
This spontaneous report was received from an unspecified reporter. Between 06-FEB-2017 and 07-FEB-2017, 9 doses of ROTATEQ (lot number M016918 with expiration date of 15-FEB-2018, and lot number reported as M31553 with expiration date of 19-MAR-2018), were improperly stored with a minimum temperature of -0.2 degrees Celsius during 5 hours and 59 minutes with an alarm trigger time at 12:15 hours and alarm ambient temperature of 22.1 degrees Celsius on 06-FEB-2017, and a minimum temperature of 0.1 degrees Celsius during 5 hours and 39 minutes with an alarm trigger time at 00:37 hours and alarm ambient temperature of 21.1 degrees Celsius on 07-FEB-2017. The upper alarm limit status was "ok". As of 08-FEB-2017, the doses experienced a minimum temperature of 1.9 degrees Celsius during 19 minutes with a status reported as in progress". The most recent temperature excursion for ROTATEQ was between 0 degrees Celsius and 2 degrees Celsius for 7.5 hours. In addition, it was reported that the upper alarm limit was above 8.0 degrees Celsius for 1 hour, and the lower alarm limit was below 2.0 degrees Celsius for 15 minutes. Additional information has been requested. Sender's Comments: US-009507513-1702USA007965: US-009507513-1703USA006475: US-009507513-1703USA006476.
Patient apparently developed severe arthralgias and swollen joints approximately 2-3 days following administration of the high dose influenza vaccine for seniors. An inflammatory process of the R wrist and knee joints was documented along with functional decline, arthralgias, and sudden inability to ambulate. This vaccine was administered by a local home health agency operated by a local county health department. The husband and wife both received the vaccine and both developed similar symptoms.
pt recv vax 5JUL95 & 3NOV97 pt exp a moderate rxn rash all over body that consisted of blisters around the hairline, red spots that turned into blisters;some had clear & other yellow centers;
WITHIN 24 HOURS OF SHOT: FATIGUE, MUSCLE ACHES, INJECTION SITE SORE, HEADACHE (LIKE SINUS PRESSURE) 24 HOURS AFTER SHOT:  SWOLLEN LYMPH NODE, CHILLS, FEVER (100.4) 36 HOURS AFTER SHOT:  LIKE NOTHING EVER HAPPENED
Information has been received from a nurse concerning a female with no pertinent medical history and no drug reactions/allergies who on 06-APR-2010 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (LOT# not reported). There was no concomitant medication. On 06-APR-2010 the patient experienced a knot at the injection site and a sore arm. There was no lab study or diagnostics performed. Unspecified medical attention was sought. At the time of reporting, the patient had not recovered. Follow-up information has been received from a nurse who reported that the 25 year old (also reported as 24 year old) female patient who on 06-APR-2010 was vaccinated intramuscularly into the left deltoid with the second 0.5 mL dose (previously reported as first dose) of GARDASIL (LOT# 1487Y). The nurse reported that the patient called to let their known that she had slight hardening around injection site and area was tender to the touch -effects subsided when called patient back on 11-APR-2010. No further information is available.
Really pink; Hard; Scratchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Really pink), VACCINATION SITE INDURATION (Hard) and VACCINATION SITE PRURITUS (Scratchy) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040521A and 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Really pink), VACCINATION SITE INDURATION (Hard) and VACCINATION SITE PRURITUS (Scratchy). At the time of the report, VACCINATION SITE ERYTHEMA (Really pink), VACCINATION SITE INDURATION (Hard) and VACCINATION SITE PRURITUS (Scratchy) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported. No treatment medication were reported.
Patient says the arm was sore when given the immunization that the soreness did not go away, to the point where she can't hardly use the arm. Describes the pain as a nerve pain that was relieved partially when she was on steroids the Her dr had prescribed her on 2/17 for the pain.
4 days post vaccine, 02/26/2021- a broke out into hives  on fore arms, a big chunk of my body. I treated it with Benadryl. It lasted only 1 day.  2 weeks after vaccine-  a swollen lymph node on my neck. I treated it with ibuprofen and that only lasted a day.
very red face, dark red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (very red face, dark red) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (very red face, dark red). At the time of the report, ERYTHEMA (very red face, dark red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not reported.  Treatment information was not provided.