chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme tiredness; Sleepiness; Chills; Not feeling well; Dizziness; This is a spontaneous report from a contactable Consumer. This Consumer (Patient) of unspecified age and gender reported that the patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date were not reported) via an unspecified route of administration, on 15Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, in the afternoon the patient experienced extreme tiredness, sleepiness, not feeling well and chills. The patient got feeling that it would go away and it has not really gone away. The patient thought by this time it would be over, and was feeling sleepy, tired, not feeling well. The patient was treated with 2 pills for dizziness. The outcome of events is not recovered. Information on Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Symptoms began on Dec. 23rd with sensitivity and then itching on the chin. By the next day there were raised vesicles above the upper lip on the right side.  By Dec. 25th, the vesicles leaked fluid and a lesion appeared that was very itchy. Eventually, the lesion expanded to quarter-sized and took three weeks to completely resolve.  A faint pink scar remains.
This is a spontaneous report from a contactable consumer (patient). A 27-year-old (non-pregnant) female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER8727), at the age of 27, via an unspecified route of administration, left arm, on Mar 31, 2021, at 09:30, single dose, for COVID-19 immunisation. Medical history not reported. The patient has no known allergies to medications, food or other products. Concomitant medications included the birth control for unknown indication, from unknown date and unknown if ongoing. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On Apr 1, 2021, at 00:00, patient experienced 103 fever overnight and then vomited the entire next day. The patient underwent lab tests and procedures, which included body temperature on Apr 1, 2021, at 00:00: 103ºF. The outcome of the event 103 fever overnight and vomited the entire next day: unknown (at the time of this report). No follow-up attempts needed. No further information expected.
SEP93 c/o feeling of tired; NOV93 devel flu-like sx; 10DEC93 jaundice & vomiting & was hospitalized; devel acute liver failure of unknown cause & thrombocytopenia secondary to aplastic anemia; despite platelet transfusions, no improvement;
Patient received a dose of Pfizer vaccine.  It was noted that the vaccine 5 day expiration date/time was 5/12/2021 @ 930 am.  Vaccine was administered to patient at 10:08 am on 5/12/2021.  No adverse reactions noted during observation period.  MD and management team aware.
Friday 10/23/09: developed cough and runny nose.  10/24/09 began vomiting. 10/25/09 temperature of 105.2 degrees farenheit.  Difficulty breathing.  Went to the ER.  Monday 10/26 followed up with pediatrician.
shingles; This spontaneous report was received from a lawyer and refers to a patient of currently 61 year-old of unknown gender concerning a case in litigation. The patient's concurrent conditions, medical history, historical drugs and concomitant medications were not reported.  In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced herpes zoster and was treated with unspecified medications.  The outcome of herpes zoster was unknown.     The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and got vaccinated) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.  No Medical History information was reported.   On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 15-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and got vaccinated). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 15-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and got vaccinated) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient stated that she did not want to register for the pregnancy form and that she didn't experience any side effects and was feeling fine.  No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
expired drug used; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 48-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number HF2YA, expiry date 15-JUL-2023) for prophylaxis.   On 25-JUL-2023, the patient received Boostrix. On 25-JUL-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: expired drug used). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 26-JUL-2023 Nurse reported that a dose of Boostrix was given to a patient, but it was expired, which led to expired vaccine used. The reporter did not consent to follow up.
Pt Reported feeling nauseated, wanted to vomit, loss consciousness while seated, kept safe while experiencing seizures like symptoms, jerking of body muscles, drooling, diaphoresis, paleness, no emesis. Pt recovered withing 15 minutes.
Massive headache at front of head, dizziness, ringing in ear, nausea, restless, diarrhea, stomachache, shallow breathing, hearing sensitivity, exhaustion, sleep sweat, lack of appetite.
Per the patient, in the evening after she received the vaccine she started to have an itching sensation that began at the site of injection and traveled all down her arm and eventually across her chest.
Injection site warmth; Pain in other arm; Injection site pruritus; Injection site swelling; 2-3 eye blood capillaries exploded; A spontaneous report was received from a health care professional concerning a 33-years-old female patient who received Moderna's Covid-19 Vaccine (mRNA-1273) and experienced 2 or 3 eye blood capillaries had exploded, itchy in the site of injection, injection site swelling and felt pain in the other arm(not in the one were got the vaccine).  The patient's medical history includes hypothyroidism. Products known to have been used by patient, within two weeks prior to the event, included methimazole, proponalol, citalopram.  On 04-Jan-2021, approximately one day prior to the events the patient received their first of two planned doses of mRNA-1273 (Batch number: 026L20A) intramuscularly into the left arm for prophylaxis of COVID-19 infection.  On 05-Jan-2021, patient experienced 2 or 3 eye blood capillaries exploded, also experienced symptoms including itchy in the site of injection, swelling and warmth in the site of injection and pain in the other arm. Treatment for symptoms included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event 2 or 3 eye blood capillaries exploded was considered resolved on an unknown date. The outcome of an events itchy in the site of injection, swelling and warmth in the site of injection and felt pain in the other arm was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
SORENESS; VACCINE EXPOSURE DURING PREGNANCY; MILD FATIGUE; This spontaneous pregnancy report received from a parent concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and no alcohol use, and other pre-existing medical conditions included the patient was pregnant at the time of reporting. the patient had no known allergies. the patient had no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced mild fatigue. On 08-APR-2021, the subject experienced soreness. On 08-APR-2021, the subject experienced vaccine exposure during pregnancy. The date of the subject's last menstrual period and expected delivery date were not reported. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness, and mild fatigue on 09-APR-2021, and had not recovered from vaccine exposure during pregnancy. This report was non-serious.
Red macular rash started at neck/chest and went to rest of trunk, arms, legs 12 days after vaccination, was starting to fade Day 13 also diarrhea.
FEVER 101, VOMITTING BEGAN ON 07-27-2017 CONTINUED THRU 7-29-2017 THEN RESOLVED.
The influenza vaccine Fluarix was administered after a temperature excursion that the vaccine was not viable.
Patient reports pain in entire left arm, not just at the injection site. Difficult to move arm.
Patient   Admitted Medical Center, 11.12-2022 thru 12.5.200  (COVID+)  Admitted Medical Center ER 12.10.2022- (FLU+)  Expired 12.12.2022  1059
tingling sensation; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of tingling sensation in a elderly female patient who received Herpes zoster (Shingrix) (batch number 597C4) for prophylaxis.   The patient's past medical history included breast cancer (number of years ago) and lumpectomy (number of years ago).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced tingling sensation (Verbatim: tingling sensation). The outcome of the tingling sensation was resolved.   It was unknown if the reporter considered the tingling sensation to be related to Shingrix.   It was unknown if the company considered the tingling sensation to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-AUG-2023 and 07-AUG-2023 The reporter clarified that the patient had a lumpectomy due to breast cancer a number of years ago.  After receiving Shingrix, the patient developed a tingling sensation where the lump was removed.  Not sure what side the lump was removed from and therefore not sure if Shingrix was administered on the same side or not.  Unsure if lymph nodes were removed.  The reporter stated that the patient mentioned this did not happen with other vaccines (COVID, flu, etc).  She received Shingrix two months ago and the tingling went on for several weeks following vaccination but then went away.
Less than 50 maculo-pap rashes - over body - more upper & more centripetal, body ache, malaise, itch on 16th day post vaccination.
Left arm swollen, hot, with itching at site. Severely swollen part way to elbow next day after immunizations. Benadryl provided relief. Recovered by 3 days after immunizations.
Me and my wife went to the local pharmacy to have immunization for Chicken Pox to clear our medical in May this year. We were given vaccination for ZOSTAVAX. We came to note that the immunization claim was rejected by our Medical insurance stating that it is covered only for 60+. We went straight to Pharmacy and told them about the situation and $473 was refunded. Moreover the Doc who cleared our medical also did not note that.
11/29/22 covid shot: Patient said bruised at the injection site and about a week later, a little bit of blood came out of the bruise. She did not follow up with the doctor. She has frozen shoulder currently and has had in her left arm for about 2 years, where she cannot lift up her arm high. She said that she thought the male pharmacist hit the bone, he was standing while giving the shot, and she thought he did the shot too high.
Patient notes a few minutes after receiving vaccination she began to have throat tightness and her tongue felt "funny". No sensation of throat closure, SOB or chest discomfort. Patient evaluated and vitals were stable. She was given 50mg Benadryl IM at 2:55p. Patient observed for 1 hour and after this she reports feeling well, no symptoms reported. Vitals were stable. Patient discharged to home and advised to make sure she has someone driver her to have the next vaccination
TROUBLES WITH BLOOD CLOTS; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, batch number and expiry date were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient had troubles with blood clots. As per reporter, "my brother and my friend were now having troubles with blood clots. My friends daughter now was suffering with an autoimmune disease and the list goes on. Makes me sick what was happening to people now" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220313555 and 20220313665.; Sender's Comments: V0-20220313549-COVID-19 VACCINE AD26.COV2.S- troubles with blood clots. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Swelling arm/ swelling down to their biceps after receiving the COVID-19 Vaccine; arm soreness/ soreness in their arms after receiving the COVID-19 Vaccine; light redness around the vaccine injection site; body felt cold; felt real tired right after; fell asleep quickly; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 13:00 at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported the patient got the COVID-19 Vaccine at the same time as her husband did, and she had some symptoms afterwards, but her symptoms went right away. It was reported both she and her husband had soreness in their arms after receiving the COVID-19 Vaccine. She said a micro needle was used when the COVID-19 Vaccine was administered to both her and her husband's left upper arms. It was also reported both her and her husband had swelling down to their biceps after receiving the COVID-19 Vaccine. She said the swelling went away on both of their left arms after 12-14 hours. It was also reported the husband and his wife continuously monitored each others vaccine injection sites. She said the husband used a LED light to look at her left upper arm, and saw a light redness around her vaccine injection site. The husband said the light redness around the vaccine injection site went away in 2 hours after receiving the COVID-19 Vaccine. It was reported her body felt cold after receiving the COVID-19 Vaccine on 28Dec2020, and that she felt real tired right after she noticed her body felt cold. The husband said his wife fell asleep quickly on 28Dec2020, which is not normal for her, and slept for awhile. The husband said after she woke up she was fine. It was reported their arm swelling and soreness didn't really effect either one of them right away. He said the vaccine injection site redness for his wife started about 45minutes to an hour after she received the COVID-19 Vaccine. He said they both started to feel the soreness in their left arms later. He said he  could feel the soreness at the vaccine injection site when he moved his left arm. He said it was the same for his wife when she moved her left arm, clarifying it was a very subtle feeling of soreness. The outcome of the events was recovered.  Lot/Batch has been requested.
Headache, Fever, Swelling at injection site Narrative:  Per nursing report: "took 2nd dose of Moderna vaccine on 2-3-21. C/o fever of 101.3, headache and left arm swelling. Did not come to work on Wednesday [2/3] and Thursday [2/4] due to headache and fever.   Other Relevant History:
This spontaneous report as received from a Medical Assistant refers to 16 year old patient, gender not reported. On 19-NOV-2014, the patient was vaccinated with GARDASIL, Lot # K004204, expiry 12-JAN-2017, dose unspecified. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event reported. This is one of the several reports from the same reporter. Additional information has been requested.
The vial experienced excursion in the refrigerator on 03OCT2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes; No adverse event; Adult patient received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Adult patient received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial experienced excursion in the refrigerator on 03OCT2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Adult patient received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The vial experienced excursion in the refrigerator on 03OCT2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Adult patient received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial experienced excursion in the refrigerator on 03OCT2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Adult patient received Bivalent booster from vials that experienced excursion in the refrigerator on 03OCT2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (The vial experienced excursion in the refrigerator on 03OCT2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes).    No concomitant medication details was reported. It was reported that excursion occurred in refrigerator on 03-Oct-2022 with minimum temperature of 1.76 Celsius and maximum of 1.97 Celsius for 1 hour 40 minutes. It was the first time the excursion occurred. It was also reported that some vials were stored and some were discarded after excursion. No treatment medication details was reported.  This case was reported for patient 5 of 11 adult patients.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 11-MAR-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R019391 with expiration date 05-JUL-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373: