chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 POSITIVE; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 19-AUG-2022. The patient's weight, height, and medical history were not reported. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient received booster with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin not reported, batch number: 1828906 expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. No concomitant medications were reported.  On 17-AUG-2022, the patient experienced covid-19 positive (Dose number in series 2). Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000246966.
Rash & RASH VALACYCLOVIR 1000 MG TID TAKE ONE TABLET BY MOUTH THREE TIMES DAILY
she had an allergic reaction to the first dose; tongue swelled; her bottom lip went number for 1/2 hour; Swollen tongue and her lips was numb; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL1283), via an unspecified route of administration, administered in arm right on 22Jan2021 (at the age of 59-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced she had an allergic reaction to the first dose, tongue swelled, her bottom lip went number for 1/2 hour, swollen tongue and her lips was numb, all on an unspecified date in 2021. Patient is scheduled to have the second dose of the Pfizer COVID-19 vaccine tomorrow (12Feb2021). Her vaccination provider said that she cannot give her the second dose since she had an allergic reaction to the first dose. Patient went to her doctor but her doctor said that he does not have access to the vaccine. Patient claims her allergic reaction is not severe. Patient only have a few days before her second dose. What do I do if I can't take it on time. Patient stated that she took the first Pfizer shot and tomorrow is the due date for the second one. Stated she cannot get it because she had small allergic reaction to the first one. Stated that her doctor can give it but she cannot because she cannot get it to her clinic. Wanted to know what to do. Is for the Pfizer Covid 19 shot. Stated that her tongue swelled and her bottom lip went number for 1/2 hour. Event details: Stated that her tongue swelled three weeks ago. Recovered completely. Stated that her bottom lip went numb three weeks ago. Recovered completely. Verbatim and event description: Swollen tongue and her lips was numb after she took the 1st dose of vaccine. The patient did not receive treatment for the events. Outcome of the events tongue swelled, her bottom lip went number for 1/2 hour was recovered on an unspecified date in 2021 and outcome of remaining events was unknown.  Follow-up (PRD/SRD 14May2021): Follow-up attempts completed. No further information expected.
Rec'd MMR on 6/11/09. Patient states had bumps on face and right knee 6/15/09 about the size a dime with a little head in center. Exam on 6/19/09 few papules scattered on face and one on right knee decreased to pea size and dry. Resolving. No treatment needed.
tiredness and it has worsened she is so tired all the time.; Stomach pain; Diarrhea; Headache; Tiredness; Injection site pain; Chills; feeling unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (Lot number: EL9267) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lung problem" (unspecified if ongoing), notes: prior to the received the COVID vaccine. There were no concomitant medications. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 06Mar2021, outcome "not recovered", described as "Stomach pain"; DIARRHOEA (non-serious) with onset 06Mar2021, outcome "not recovered", described as "Diarrhea"; HEADACHE (non-serious) with onset 06Mar2021, outcome "recovered" (08Mar2021), described as "Headache"; FATIGUE (non-serious) with onset 06Mar2021, outcome "not recovered", described as "Tiredness"; VACCINATION SITE PAIN (non-serious) with onset 06Mar2021, outcome "recovered" (08Mar2021), described as "Injection site pain"; CHILLS (non-serious) with onset 06Mar2021, outcome "recovered" (08Mar2021), described as "Chills"; MALAISE (non-serious) with onset 06Mar2021, outcome "unknown", described as "feeling unwell"; FATIGUE (non-serious), outcome "unknown", described as "tiredness and it has worsened she is so tired all the time.". No follow-up attempts are possible. No further information is expected.
1st shingles vaccination. Swelling about 4" diameter and hot around injection site. Fever. Body aches. Bad enough I don't want another one!
10 days after 1st Moderna dose, I developed the COVID Arm...  delayed cutaneous hypersensitivity. It was like an inch under the injection site that started off as a bruise and later became swollen and was itchy. With the 2nd Moderna dose, a little over 12 hours later,  I had a spontaneous nose bleed. I have had 3 additional spontaneous nose bleeds from the same nostril which have been difficult to stop.
Initial report received on 25 October 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in an 4-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 1 dose of DAPTACEL; lot number C2934BA on 30 May 2008, 2 doses of PENTACEL; lot number C3176AA on 23 July 2008 and 09 October 2008 and another dose of DAPTACEL; lot number C3157AA on 09 November 2009 (routes and sites of administration not reported). The subject developed cough on 03 August 2012, approximately 2 years and 8 months after the last dose. Paroxysmal coughing, without a whoop, began on 07 August 2012. Laboratory testing included positive PCR on 13 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 13 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 07 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 35 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 6 decade old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on an unspecified date in MAR-2021 for prophylactic vaccination. Dose number series was 1. The batch number was not reported and has been requested. No concomitant medications were reported.  After few days on an unspecified date in NOV-2021, patient was diagnosed with Covid-19 and had mild symptoms for a couple of days (suspected clinical vaccination failure and suspected covid-19). Patient was in good health. On 06-NOV-2021 patient 8 year old daughter who was exposed at school, got sick and was diagnosed with covid-19 and had flu like symptoms for about 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on NOV-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000204609.; Sender's Comments: V0: 20211164394-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Information has been received from a physician concerning a patient female who in July 2008 was vaccinated with GARDASIL vaccine 0.5 mL IM. The physician reported that the patient fainted "last week" in July 2008 after receiving GARDASIL vaccine. The patient sought medical attention; she was seen in the physician office. ("AE occurred in the office"). There was no product quality complaint. No lab diagnostics were performed. On unspecified date the patient recovered. Additional information has been requested. This is one of several reports from the same source.
Fever, joint pain, fatigue, body ache, lung discomfort?  I rested and used emergency inhaler.
Pfizer-BioNTech COVID-19 Vaccine EUA: During vaccine administration patient complained of flushing, lightheadedness, dizziness, and arm tingling. No loss of consciousness, respiratory symptoms, or gastrointestinal symptoms reported. Inital vital signs: Blood pressure 147/84 mmHg, heart rate 115 beats per minute, oxygen saturation 95% on room air. Repeat vitals ten minutes later: blood pressure 123/60 mmHg, heart rate 77 beats per minute, oxygen saturation 98% on room air. Patient monitored for 30 minutes. Symptoms improved with time and snack. Patient was discharged in stable condition.
I have had 2 similar events to This vaccine.   1- A week or 10 days after 2nd dose (given at local Mass Vaccination drive through, Lot EP-7534 on 17Mar2021) 2- Day after 3rd dose (booster)  For 1 to 3 days or so... My vision is very much delayed, lagging and some blur. Cannot seem to focus without effort and images seem to drag along line of sight. This got better after a few days at 2nd dose, but not sure how long it will last with 3rd dose as I just got it yesterday.   The side effect did start much faster with 3rd dose, next day vs. 2nd dose took about 7-10 days post 2nd dose to start.
10-3-07 resident received Pneumonia and Flu vaccine in the same injection. On 10-05-07 erythema noted at the site.
Patient received 1st dose Moderna Lot #041B21A on 4-14-2021. Today for the 2nd dose, the nurse administered Pfizer Lot#EW0177 instead of Moderna to patient.
Sharp tingling down left arm with administration. Sharp pain in arm for 1-2 hours after vaccination.
COVID+ since 8/16/21, today was feeling generally weak and SOB. EMS report high fever of 105
20 year old c/o tingling sensation in distal fingers 1st and 2nd digits, and a red dot at injection site. No other sx. ROS unremarkable. Third shot.
First shot of COVID-19 vaccine was administered on left arm.  Hives /red bumps appeared on right forearm over 3.5 hours after the shot was administered.  Diphenhydramine was administered after hives appeared and resolved within about 30 minutes of administration.
Woke up the following day after vaccine administration with sx, unsure of exact time of onset. Initially had eye swelling and progressed to hives. However continues to have 3 days of intermittent hives with no known exposure.
Compression fracture; Shingles; This case was reported by a consumer via call center representative and described the occurrence of compression fracture in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced compression fracture (serious criteria hospitalization) and shingles. On an unknown date, the outcome of the compression fracture and shingles were unknown.   It was unknown if the reporter considered the compression fracture and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix one and half year ago. Meantime, the patient was hospitalized for compression fracture and had attack of shingles. The reporter consented for follow up.
Headache, Sedation, Myalgia, Arthralgia, Fever, CHILLS Narrative:
Had a mild case of omicron; Had a mild case of omicron; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had a mild case of omicron".  Clinical course: Caller was a physician residing in withheld. He wants to know when the vaccine will be approved. He also mentioned that he has a friend who was a doctor as well and had a lecture. He mentioned that his friend has had the Covid vaccine and the booster but the friend has had a mild case of omicron. He stated that his daughter got vaccinated and yesterday was tested positive. She was trying to find out if it was Omicron or something else. He basically wants to know when the vaccine will be available (approved). He also stated that he heard that they have started human trials but he was not interested in participating in the Covid trial.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.,Linked Report(s) : US-PFIZER INC-202200295286 same reporter/patient/drug/AE, different patient
Patient received Pfizer dose #2 9/8/2021 then c\o swelling to lips and throat. Patient given Benadryl 25mg IM as ordered by onsite staff. On site staff was unable to visualize any edema. Patient verbalized resolution of symptoms prior to discharge.
Pt developed hives, as described by the pt,  the day after admin.  It continued for 5 days.
Patient stated that about a week after receiving 1st dose, he had back acne, and ear inflammation.  Patient stated that he also had ear acne.  patient visited dermatologist and was treated for back acne, patient stated the ear is still inflamed and causing pain.
After all four vaccines administered, 2 minutes had passed, patient slumped forward and fell to floor. He was unconscious for approx. 2 minutes. He then rested in office for 45 minutes. Small contusion to (L) shin. Sent home w/ instructions to drink fluids, rest, and take TYLENOL.
pt had high fever (104 - 105); pt adm to hosp dx virus infection;
I gave client his vaccine. I gave one other vaccine and noticed that he was pale and putting his head down. I asked if he felt alright. He said he was dizzy. He was at this point dizzy, pale, sweating, low heart rate in the 30's. We put a cold wet rag on the back of his neck and monitored. We gave him some cold water also. Slowly over the next 5-10 minutes his stats got better, color returned, and was not sweating anymore. He did not feel dizzy anymore.  We monitored for an additional 30 minutes. Gave instructions. Sent home with spouse.
The arm got very swollen, red and warm to the touch.  It was itchy, stinging and lasted about one week.
29APR92 pt recvd vax approx 10AM & by late afternoon became irritable, crying, & temp elevated; 7AM following day t103.1 & returned to office same afternoon;
Within a few days of receiving the MMR and varicella vaccinations (administered at1 year of age), pt lost speech, became increasingly withdrawn and distant, and difficult to deal with. He had almost 20 words, and lost the ability to say any. Now has diagnosis of "developmental delay." He is making some progress now, 1 1/2 years later. Per medical record, pt experienced language delay.  Nurse follow up on 05/27/04 states: "Complete."  Per annual report-speech delay, elevated heavy metals, developmental delays.
Redness, swelling, itching at injection site Noticed the next morning, took Benadryl 1/7/21 at 9pm Still the same today 1/8/21
Missed second dose in recommended time frame; 3 shot pain in thigh muscle; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed second dose in recommended time frame) and MYALGIA (3 shot pain in thigh muscle) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Concomitant products included METOPROLOL and AMLODIPINE for Hypertension, LORAZEPAM for Sleeping sickness, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMIN C [ASCORBIC ACID] for Supplementation therapy.    On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed second dose in recommended time frame) and MYALGIA (3 shot pain in thigh muscle). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed second dose in recommended time frame) outcome was unknown and MYALGIA (3 shot pain in thigh muscle) had resolved.            This case was linked to MOD-2021-211621 (Patient Link).
Greater than 35 days between doses of Moderna Covid-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between doses of Moderna Covid-19 Vaccine) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between doses of Moderna Covid-19 Vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between doses of Moderna Covid-19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Starting a few days after receiving the vaccine, I experienced the typical "fatigue" that most people describe. The following day I started having GI issues and I was out of work for a few days. The following week I saw the doctor due to severe diarrhea. I do not have IBS but felt like I was having an IBS attack. She checked for parasite and other tests to ensure something else wasn't causing it but all came back negative/normal. I treated myself at home with Imodium and after about 3 weeks I was back to normal.
shingles; Information has been received from a lawyer referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or about 02-FEB-2009, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for long-term prevention of shingles and/or zoster-related conditions.   On an unknown date, the patient experienced shingles. The patient did not recover from the event. The patient received the treatment. As per the reporter, the patient has and will continue suffer significant medical and related expenses as result of the injury which costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies. The patient was hospitalized due to the event on an unknown date.  The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).
I did not have a period x 2 months following my 2nd covid vaccination. Then had a period for 5 months with extreme abdominal cramping and bloating, andendometrial lining inflammation that was confirmed on a transvaginal u/s. I had 3 transvaginal ultrasounds to follow up on the inflammation. I took progesterone for 4-5 months to reduce the thickness of my endometrium. I had a biopsy that was benign, I then had a hysteroscopy with dilation and curettage procedure. My follow up ultrasound following progesterone treatment and the dilation and curettage showed a decrease in the endometrial inflammation.  There was no other explanation for the abrupt thickening of my uterine lining other than the fact that I received the covid vaccine prior to the start of these  symptoms.
24 hrs post vax given in lt arm mom noticed redness & some swelling; Very warm to touch; Temp 101.4, 7cm x 4cm wide p/24hrs; tx Keflex;
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 11-JUL-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number reported as H015557, expiration date 16-AUG-2014) (dose and route not reported) that was stored in improper temperatures. This is one of several reports from the same source. Additional information is not expected.
elevated blood pressure of 216/99; received telephone order to administer 0.1 mg clonidine and patient to hold next dose of midodrine.
I woke up with a fever of 101 and the next day I had achiness and chills. I tested positive for COVID-19 after taking  an at home test-September 12, 2022, I called the provider, and she did a telehealth appointment with me and prescribed Paxlovid and Loratadine.  After 2 days, all symptoms were gone. My temp was down to 99 but I felt much better. By the following day, I felt fine.
Initial unsolicited report received from a non-healthcare professional (Practice Manager) on 18 November 2016. This case involves a 45-year-old female patient who was inflicted with injury (from a shattered ACTHIB vial) of PENTACEL (batch number: C5223AA, expiry date: 16 July 2017, route, dose and dose in series were not reported) via right index finger in the on 18 November 2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not provided and Illness at the time of vaccination was reported as none. Concomitant medications were not reported and any other vaccinations within four weeks of vaccinations were also not reported. On 18 November 2016, the patient had a cut in her index finger on broken glass from a shattered ACTHIB vial. It was also reported that the patient had first aid to her finger and applied a bandage and no stitches required. The patient required emergency room (ER) visit. Laboratory investigations were reported as none. Corrective treatment was not reported. The outcome of event was reported as not recovered. List of documents held by sender: none.
Rash - Red, papular to trunk & limbs 3 days after vaccine - lasted one week - No treatment