chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I've had two incidents of rectal discharge since receiving the second shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13May2021 10:30 (Lot number: EW0167) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Systemic Lupus Erythematosus" (unspecified if ongoing), notes: Verbatim: Systemic Lupus Erythematosus. Concomitant medication(s) included: VIMPAT. Past drug history included: Penicillin, reaction(s): "allergy", notes: known allergies : Penicillin (reaction when I was a baby, haven't had again). Vaccination history included: Bnt162b2 (Lot number: ER8735, Administration time: 01:30 PM, Dose number: 1, Vaccine location: Left arm), administration date: 21Apr2021, when the patient was 45 years old, for COVID-19 Immunization. The following information was reported: RECTAL DISCHARGE (non-serious) with onset 14May2021, outcome "unknown", described as "I've had two incidents of rectal discharge since receiving the second shot.". Therapeutic measures were not taken as a result of rectal discharge.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications received within 2 weeks of vaccination included Vimpat. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that the patient had two incidents of rectal discharge since receiving the second shot. The first the day after and the second 4 days later. There was no Hospitalization Prolonged.  Follow-up attempts completed. No further information expected.
Information has been received from a nurse practitioner concerning a 37 year old female who on 28-SEP-1998 was vaccinated with the first dose of VARIVAX (Merck) and on 31-OCT-1998 was vaccinated with the second dose of VARIVAX (Merck). The patient had a negative titer on 16-AUG-2007 (less than 0.91, no units specified). No problems reported. It was not reported if the patient sought medical attention. Additional information has been requested.
16 hr post injection: sore arm, headache 20 hr post injection: body aches, headache 26 hr post injection: body aches increase, chills, fever (Tmax 101.2 36 hr post injection: back to normal baseline state
Delay in menstrual cycle.   When cycle began, it lasted abnormally long.   Bleeding occurred for more than 19 days.
This case meets vaccine breakthrough criteria review; known COVID exposure.  SxS include fatigue, cough
Syringe and needle disconnected causing vaccine to leak.  Patient was successfully given another dose.
Disease recurrence; Gastroparesis; Sitophobia; Syncope; This is a literature report for the following literature source(s):.  A 57-year-old man developed gastroparesis following COVID-19 vaccination with tozinameran, and developed akathisia during treatment with metoclopramide for gastroparesis. Additionally, he exhibited lack of efficacy during treatment with ondansetron, baclofen, famotidine and prochlorperazine for gastroparesis [dosages not stated; not all routes, time to reactions onset and outcomes stated]. The man previously healthy, received the first dose of tozinameran [Pfizer BioNTech COVID-19 vaccine] in December 2020. Five days after the vaccination, he developed intractable nausea, hiccups and vomiting. During following week, he needed three emergency department visits for symptoms, which were refractory to oral prochlorperazine, ondansetron and fluid resuscitation. Subsequently, he received baclofen, but showed no symptom relief. For presumed gastroparesis, he started receiving metoclopramide which provided significant relief; however, he developed extrapyramidal symptoms of akathisia. Therefore, metoclopramide was withdrawn. Due to persistent symptoms, the man received erythromycin, which nearly resolved on second week. Therefore, his prokinetics were tapered off. He received the second dose of tozinameran following 23 days of the first dose. He again developed recurrent intractable nausea, hiccups and vomiting within 2h associated with near syncope and sitophobia. Domperidone was initiated providing minimal improvement. Gastric emptying study revealed delayed gastric emptying. Thereafter, high-dose famotidine was given with no relief. After initiating prednisone, his symptoms resolved within few days. Prednisone was successfully taper off within 2 weeks. At 2 months after cessation of steroid, he remained asymptomatic.  Sender's Comments: Based on the information provided in the narrative , a possible contributory role of the suspect vaccine BNT162B2 to reported event of gastroparesis , syncope and disease recurrence cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101668421 Same article/patient/drug and Different event;
Pt c/o severe pain, swelling, and redness in left arm starting several hours after vaccination that was unrelieved by analgesics.  Progressed to low-grade temperature, chills, and fatigue an hour after noticing marked swelling and pain.  Symptoms lasted for over 36 hours until resolving around 48 hours after injection, to nearly completely resolving 72 hours after injection.
Pt had some redness and swelling to injection site and small lump under skin. Pt was given Prevnar and Pentacel in same leg. Unsure which vaccine caused reaction.
Chest tightness and minimally SOB; weakness, chills generalized feeling of being yucky; did see provider and CXR and EKG normal.  States low-grade fever lasted couple of days.
Yesterday, 4 weeks after the seconddose- the pain has returned at the injection location (same upper right arm). It feels like I've been repeatedly punched. It hurts more today.; After second dose- Had some pretty severe pain at injection location (upper right arm) that subsided and went away after a few days.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ep7534) via an unspecified route of administration in the right arm on 16Mar2021 at 08:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6203) via an unspecified route of administration in the right arm on 23Feb2021 at 08:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. On an unknown date in Mar2021, after second dose, the patient experienced some pretty severe pain at injection location (upper right arm) that subsided and went away after a few days. On 18Apr2021 at 15:00, 4 weeks after the second dose, the patient experienced the pain had returned at the injection location (same upper right arm). It felt like she had been repeatedly punched and it hurted more on the day of reporting. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were  taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, after second dose some pretty severe pain at injection location (upper right arm) that subsided and recovered after a few days on an unknown date in 2021, while the event pain returned at the injection location (same upper right arm) 4 weeks after the second dose, felt like she had been repeatedly punched and hurted more was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Got MMR SC 10/15/02. At same sit mother first noticed a raised area with yellow discharge 11/03/02. It became red 11/5 and was seen in office 4mm raised red crusty sore without d/c and nontender.
Delayed side effect: developed red patch/rash at the site of injection on the left arm on 03/19/21 evening. The pinkish color patch was tender and a bit swollen with mild itch and also mild pain. This condition remained until 03/22/21. Today is 03/23/21 and this delayed side effect seem to be diminishing but not completely gone. I applied over the counter Cortizone cream last night to the rash area that may have helped diminish the reaction.
Received #3 injection on 10/5/21. Woke up the next morning and right leg was noticably swollen and uncomfortable. Went to ER and after ultrasound it was determined I had two blood clots between my upper thigh and ankle.
Swelling of both elbows sores on both arms red blotchy skin on both arms itching severe fatigue
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 16-JAN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-DEC-2016) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Celsius) and the type of excursion (R/F) were 72, 9 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a consumer concerning his 30 year old wife with asthma and seasonal allergies who on 14-NOV-2008 was vaccinated with PNEUMOVAX (lot# not provided).  Concomitant therapy included montelukast sodium (MSD), rizatriptan benzoate (MSD), influenza virus vaccine (unspecified) at the same time, PULMICORT.  On 17-NOV-2008 the patient became lethargic and experienced malaise.  The injection site was red, warm to touch, extremely sore, raised, and swollen.  The patient's symptoms persisted.  The patient did not seek medical attention.  Additional information has been requested.
The needle tip was not tightly attached to the syringe. When it was injected, an unknown amount of vaccine ran down the arm. The patient was presented with the CDC guidelines that if it was 1/2 or less or an unknown amount,  the injection should be immediately repeated in the opposite arm.  The patient elected to repeat the dose in the right arm.
14 hours post vaccine began having tingling, pins and needles type sensations in feet, arms, hands, occasionally trunk
unresolved right upper arm pain at site of injection radiating to right shoulder and right side of neck unresolved with acetaminophen and Aleve
This case was reported by a consumer and described the occurrence of swelling injection site in a 32-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  A physician or other health care professional has not verified this report.  On 27 October 2006 at 10:00 the subject received unspecified dose of Fluarix intramuscularly in the left arm.  On 28 October 2006, 1 day after vaccination with Fluarix, the subject experienced swelling injection site and a heat sensation at injection site.  A few days later, the subject developed injection site pruritus.  The subject also reported some injection site pain.  She treated the symptoms at the site with Tylenol and a heating pad with improvement.  At the time of reporting the events were resolved.
non-itchy one inch small bright pink slightly raised patch of skin on the side of right hand by thumb, on the inside right leg. Skin pores were red and the skin around it was pink and slightly raised; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6206, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 13Mar2021 13:45 (at the age of 62-year-old) as dose 1, single for COVID-19 immunization, at hospital. The medical history included Known allergies: Garlic (contact allergy), lobster, mussels, latex and Positional Tachycardia. Concomitant medication included fremanezumab (AJOVY [FREMANEZUMAB]) on 20Feb2021 administered in belly (other vaccine in four weeks). The patient had no COVID prior vaccination and had not been tested for COVID post vaccination. The patient did not receive other vaccine on same date as suspect product. On 13Mar2021 15:00, the patient developed "non-itchy one inch small bright pink slightly raised patch of skin on the side of right hand by thumb, on the inside right leg. skin pores were red and the skin around it was pink and slightly raised". The patient reported that she "have sensitive skin and can break out in contact dermatitis easily". No treatment was given for the event. It was reported that the patient received second dose of vaccine on 30Mar2021 01:30 PM in left arm (Lot number: EP6955) and "after 5 days developed an oblong pink rash about 4 inches long and 3 inches wide below the injection site. Doesn't itch feels like sunburn". The outcome of the event was reported as resolving.  Follow-up attempts completed. No further information expected.
Patient has regressive autism that began at 2years old.He received this vaccination and in 4 hours developed a fever to 104 and severe headache that lasted 12 hours.  I spoke with the Pediatrician's office and was told there was not much information as this was a new vaccine. I called the drug company(I am an MD A&I) who would not discuss this with me. Patient has had further significant regression over the last 2 and 1/2 years. 1/21/2010 Patient became progressively more dysfunctional in Neurological state both on a cognitive and motor level and verabal from this. This affect was profound and temporally related.
Pt had severe bump on shoulder raised about an inch at injection site. Bump was 3 inches long and 2 inches wide. Patient will put ice on area and take some diphenhydramine. If gets worse or doesn't go away will go to MD.
patient states no adverse event; patient says she does feel tired and her arm is sore at the injection site; VAERS filled out due to vaccine being given after BUD 03/06/2023 due to being kept in refrigerator since 2/4/23; original vaccine manufacturer expiration of 06/12/2023
Slept longer than usual; Triceps pain; This is a spontaneous report from a contactable healthcare professional (patient himself, physical therapist) via Pfizer colleague. A 31-year-old male patient received first dose of bnt162b2 (PFIZERBIONTECH COVID-19 VACCINE, lot number: EL9264 and expiry date: 31May2021), intramuscular on 04Feb2021 at single dose for COVID-19 immunization. The patient was vaccinated at a hospital. Medical history and concomitant medications were not reported. The patient previously received hepatitis B vaccine last 12Jan2021. On 04Feb2021, the patient reported that after the vaccination, he slept longer than usual during the night. The patient also reported that he experienced triceps pain (not at the injection site area). Clinical outcome of the event slept longer than usual was unknown, while for triceps pain was not recovered as of time of report.
Oct 1, 2011 Pt went to local drug store. Person in pharmacy giving shot said that using new technique of giving shot higher near shoulder would be less painful. Pain has continued since, saw PMD who advised 3 ADVIL three times a day. Pt did this for 1 wk. Pain started to subside bit returned in middle of last night.
Given a 3rd full dose (0.50 ml) of Moderna instead of a 0.25 ml as he did not meet the immunocompromised patient criteria.  when called he stated he was feeling fine and did not have even a sore arm.
left axillary swelling; This is a spontaneous report from a contactable other HCP (patient). A 46-year-old female patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL9261), intramuscular at Arm Left on 18Jan2021 11:15 at the 46 years old at single dose for COVID-19 immunization.  The medical history was none.  The concomitant medication was ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc(CENTRUM MULTIGUMMIES).  The Historical Vaccine was fist dose BNT162B2 for COVID-19 immunization. The patient previously took Iodine and experienced allergy. There was no other vaccine in four weeks. The patient experienced left axillary swelling on 19Jan2021 22:00. There was no treatment received for the event. There was no COVID prior vaccination. There was no COVID tested post vaccination. The outcome of the event was not recovered.
7/30/09 - 1st Gardasil shot. 8/5/09 - R eye losing vision, painless, 8/14/09 - eye exam - both abnormal eyes, visual fields. 10/12/09 - 2nd Gardasil shot. 10/23/09 - eye exam #2 - both VF abnormal R > L.
Patient complained of feeling itchy all over. No other symptoms reported. Patient was given 25mg of Benadryl and started feeling better soon after. Patient offered a second dose of Benadryl and declined stating that she would take it at home prn.
Information has been received from a health professional concerning an 8 year old child who on 7/9/01 was vaccinated with varicella virus vaccine live. On 7/18/01, the pt presented with a "break-through" chicken pox rash on the trunk of the body, with no fever. The health professional also reported about another pt (WAES01072005). No further information is available.
The pt received both pneumonia and flu immunizations in the AM. Later that day, her daughter brought her to see PHN because she was refusing to go to ER and NP's office was closed. Her left arm was marked swollen from shoulder to past her elbow and she was somewhat dyspneic. Encouraged pt to follow her daughter's suggestion of taking a Benadryl and to go to ER because of her shortness of breath. TC to her daughter and also to pt, 2 days later; she had consented to use Benadryl, continued to refuse going to the ER and symptoms subsided within 24 hours. Swelling of arm went down after "a few days".
Hospitalized 10/18/2021; COVID-19 positive 10/18/2021; fully vaccinated  Discharge Summary DO (Physician) ? ? General Medicine BRIEF OVERVIEW: Discharge Provider: DO Primary Care Provider: MD Admission Date: 10/18/2021 Discharge Date: Oct 20, 2021       Active Hospital Problems   Diagnosis Date Noted POA ? Acute exacerbation of chronic obstructive pulmonary disease (COPD) 10/19/2021 Yes ? COVID-       DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COVID-19 [U07.1] Acute exacerbation of chronic obstructive pulmonary disease (COPD) [J44.1]   HOSPITAL COURSE: Patient is a 58-year-old male who presents to the hospital with complaining worsening fever, chills, cough, shortness of breath and body aches for the past 3 days.  Patient has a medical history of severe chronic obstructive pulmonary disease and uses home inhalers regularly.  Patient also has a history of surgical procedure with zepher valves.  Patient was admitted to the hospital observation unit secondary to his shortness of breath.  He was found to have COVID-19 infection.  Patient was previously vaccinated back in January.  Patient's chest x-ray was reviewed and showed no evidence of acute infiltrative process or pneumonia.  Patient in the hospital was treated with monoclonal antibody infusion.  Patient met all criteria.  Patient did well with monoclonal antibody infusion treatment and had no reactions.  Patient was not hypoxic throughout his hospital stay.  And he was discharged home on oral steroid treatment.  For acute exacerbation of chronic obstructive pulmonary disease.  He is to follow-up closely with his primary care physician and pulmonologist.
Site soreness immediately following vaccine which dissipated quickly. HOWEVER, 4 days AFTER vaccine experienced extreme vertigo, dizziness, nausea which required an ER visit. Side effects still lingering next day.
At the end of May 1999, post vax, she developed myalgias, low grade fever, and a rash. She saw a physician on 6/11/99 with myalgias and low grade fever. She was treated with doxycycline. The pt has been on doxycycline for 5 weeks and is still not feeling great.
I had SHINGRIX vaccination on June 8 and experienced headaches the following day, I had the same thing in when I took first dose in March, but did not report at the time.
Extreme fatigue the day after getting SHINGRIX shot per patient. It lasted one day (just the day after the shot) and went away after that date. She explained her symptoms as if she had muscle relaxant.
Initial misuse report received from a healthcare professional on 11 July 2013. It was reported that, a patient was administered an expired dose of MENACTRA. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
he was positive for Covid; he was positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 75-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6203), on 18Mar2021 as dose 2, single (Lot number: ER2613) and on 30Aug2021 as dose 3 (booster), single (Lot number: FF2587, Expiration Date: 31Dec2021) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation" (unspecified if ongoing), notes: Atrial fibrillation diagnosed over 10 years ago; "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: OXAZEPAM oral (1 capsule by mouth 4 times a day 15mg on that over 20 years) taken for anxiety. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "he was positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 and treatment included Paxlovid form 08Aug2022 to 11Aug2022. Clinical course: Caller reported that her husband had went into the hospital 08Aug2022 because he fell and broke his ribs. While he was there, he was found to have Covid. He was then sent home. He had history of A-fib and was 75 years old, so he was placed on Paxlovid. Stated he only took the medicine for 3 days. When attempted for clarification on hospitalization dates and caller stated he first went in 08Aug2022. Went in around midnight and sent him home the next morning with 3 broken ribs. He was to be discharged to a nursing home, but the nursing homes required covid test and when they did it, they found out that he was positive for Covid and sent him home instead (as reported).
Breakthrough case admission after 4 vaccines Moderna 1/19/21 Lot# 029L20A;  Moderna 2/16/21 Lot# 023M20A;  Moderna 11/12/21 Lot# 013F21A;  Moderna 5/10/22 Lot# 056A22A;