chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Yesterday she had cut her left middle finger on a rusty knife that was found in the basement. So mom had called us and agreed to have ADACEL shot. It was the 1st immunization she has had, since mom has refused shots over the years. She was given the ADACEL yesterday afternoon. Last evening she was fine, but this morning at breakfast she became inconsolable. Mother has a video of her screaming, crying, inconsolable. She complained a little of her legs hurting, seemed to be holding her head a couple of times like maybe the light bothered her. No fever. Mom has been using ibuprofen every 8 hours, the last dose had been about 9:30 AM. This episode of screaming had started a while after that. Mom had called here, I had agreed to see the patient. On the way here in the car she was still screaming, but then they stopped at a gas station for her to use the bathroom. She had incontinence of some urine. It was probably around that time that the screaming stopped.
This spontaneous report as received from a nurse refers to a 10 months 12 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
POST VACCIANTION PT. REPORTS DIZZINESS, TAKEN TO MED OBS VIA WC, RREPROTS FEELING BETTER ONCE ON STRETCHER, ELEVATED BP NOTED, IMPROVEMENT NOTED, NO S/S ALLERGIC RX NOTED PER ONSITE MD. PT. ESCORTED TO EXIT IN NO APPARENT DISTRESS AT 1035.  0949 INITIAL BP LYING 182/127 HR 90 O2 STAS 98%  0957 BP SITTING 153/98 HR 77 OS SATS 99% 1008 BP 135/85 HR 76 SATS 98%  1021 BP STANDING 148/98 HR 82 O2  SATS 98%
extreme rash on both arms up to elbow; breathing problem; This is a spontaneous report from A contactable consumer (patient) reported that a patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing cancer and reported as a current cancer patient that had have both vaccines. The patient's concomitant medications were not reported. The patient experienced extreme rash on both arms up to elbow on an unspecified date with outcome of not recovered, breathing problem on an unspecified date with outcome of unknown.  Events were considered as serious with hospitalization. It is reported as the patient was rushed to hospital after first shot with extreme rash on both arms up to elbow. 3 weeks later rushed back again with extreme breathing problem and once again rash on both arms.  Information about lot/batch number has been requested.
"Moderna  COVID-19 Vaccine EUA"  Immediately felt routine  pains  in right  arm at shot sight and  just  out  of sorts.  By  6 PM I felt nauceous , headache,  pains  in  every  joint  of  my  old  body ,  cough,  chills,  virgo,  weakness , low  grade   fever, unsteady on my feet.  Unable to sleep  finally took Tylenol .   This lasted  48 hours!
Had onset of fever on Saturday 24 October 2009. Seen in ER on 25 Oct 09. No Source found for fever. Also had swelling and itching of Left arm. Fever was 102F-103F on Saturday and Sunday
In January 2022, I had a cough, sneezing, and sinus pressure. The cough lasted but 6 weeks. Then, I got Shingles in 3/23. I contacted my doctor and was prescribed methylprednisolone and acyclovir. I did this for a week and my face started to go numb. Now it is numb and hurting. I went to the doctor, and he told me I have Postherpetic Neuralgia. I was prescribed gabapentin for this. I also have UTI. My doctor has also changed my medication for Migraines. I am taking TOPAMAX, EMGALITY, and CIPRO. I am still dealing with this at this time. I also had a red welt around the vaccination site for about 2 weeks.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: Patient received vaccine on 5/7. Antibiotic prescription was sent on 5/10 and patient reported swelling/rash in injection arm that had spread to lymph nodes. Called patient on 5/12/22 and states arm is much better and no longer having issues.
COVID-19 antibody test negative; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (COVID-19 antibody test negative) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis and Psoriatic arthritis.    No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (COVID-19 antibody test negative). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (COVID-19 antibody test negative) outcome was unknown.            No Concomitant and Treatment Drug was provided by reporter.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
As per mom notice a swelling on (L) deltoid yesterday even. The swelling has decreased from yesterday to today. Mom apply. child on ZYRTEC & SINGULAIR today swollen 52 in x 5 cm redness mom said is better then before.
She had the vaccine, and within the last 2 days she has no smell and no taste.  She went to the doctor who told her to call us, and spoke with him this morning and she has an appointment to get a rapid COVID test.
Psoriasis flare-up/ Inverse psoriasis outbreak; Moderna dose received on 24-Apr-2021 and later on 02-May-2021/ in between 8 days; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up/ Inverse psoriasis outbreak) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna dose received on 24-Apr-2021 and later on 02-May-2021/ in between 8 days) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (moderate to severe chronic).   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 02-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna dose received on 24-Apr-2021 and later on 02-May-2021/ in between 8 days). On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up/ Inverse psoriasis outbreak). At the time of the report, PSORIASIS (Psoriasis flare-up/ Inverse psoriasis outbreak) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna dose received on 24-Apr-2021 and later on 02-May-2021/ in between 8 days) outcome was unknown.            Concomitant medications details were not reported by the reporter.  On an unknown date, the patient experienced inverse psoriasis outbreak. on an unknown date, inverse psoriasis outbreak resolved.  The patient reported that when she took second Covid vaccine Inverse psoriasis outbreak. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment details were not reported by the reporter.  Causality for Skyrizi(risankizumab): The reporter's causality for the event of inverse psoriasis outbreak was not provided.
Began with chills, headache, progressed to redness and pain on face, eventually much swelling of face--after 3 days went to Urgent Care--sent to ER, monitored blood pressure, given injection of steroid and rx for 5-day supply of prednisone.  After about 8-9 days, face returned to normal after skin peeled.  Headache and chills lasted 3 days before going to Urgent Care/ER
Serious gum line erosion on TWO  top left front incisors.  Both approximately 2 millimeters of gum line disappeared.
Swelling 8 1/2 x 8 1/2cm, red, itchy, not painful; onset 3/5/2000, early AM. Will use hydrocortisone (OTC) and Benadryl if needed to relieve itching.
pt recv vax 21AUG97 & on 23AUG97 pt exp swelling @ inj site (2.4cm x 2.2cm);
Warm, swollen, cutaneous reaction at site of TDAP, no evidence of flucturance.
SATURDAY Jan 18/2020: I stayed at the place for 20 mins as requested by the Nurse. Nothing happened to me during this time. At 1 pm, my throat started to swell, I felt faint and dizzy and had sneeze/ cough attack.I thought I was catching a cold. I felt sleepy and went to bad. I woke up next morning feeling nauseated. Monday, Jan 20th, the injection site started to itch and became very swollen, not like a rash, but all swollen like a huge red bump and itching  all the time. It took about 10 days to go away. Coincidentally I had already a Doctor's appointment for my  shoulder (Right one) which I was having issues w/ ligaments. I showed the red bump and he told me that it looked like a reaction to the vaccine, and if it would not go away I should seek urgent care. March 11th 2020 I had a regular check up with my PCP Dr. and I showed him the picture of my arm and told him my symptoms; he strongly advised me NOT TO GET the second dose, he was afraid I could have an anaphilactic reaction. So I never took the second dose.
I was diagnosed with Vulvar Lichen planus after my covid-19 vaccine and after the booster; LP flare after the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed, Manufacturer unknown), for Covid-19 immunization. The following information was reported: LICHEN PLANUS (non-serious), outcome "unknown", described as "I was diagnosed with Vulvar Lichen planus after my covid-19 vaccine and after the booster"; LICHEN PLANUS (non-serious), outcome "unknown", described as "LP flare after the vaccine".  Additional information: As reported patient was diagnosed with Vulvar Lichen planus after his covid-19 vaccine and after the booster, and had oral Lichen Planus. patient want to report LP flare after the vaccine. Patient was due for his next booster but worried about another flare  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt called today and stated she has diarrhea cause by vaccine. I called patient twice throughout the day to check to see how she was feeling. Last call was at 5PM and pt stated diarrhea had slowed down and was feeling better.
12/30/2020 mild nausea all day, limited range of motion in left shoulder, uncontrollable shivering (600 mg Motrin 4:30 pm/ 800 mg Motrin 11:30 pm) 12/31/2020 arm soreness very uncomfortable, nausea most of the day 1/1/2021 9:00 am rash on chest, right and left forearm used hydrocortisone cream and it subsided. 1/2/2021 Itchy all day, nausea and diarrhea 7 pm through out night, mild rash all over body around 11 pm 1/3/2021 felt fine all day 1/4/2021 Felt very sensitive left side supraclavicular lymph node, very prominent, sore throat, headache 1/5/2021 Saw doctor at work place clinic regarding lymph node. Determined to be about 1 cm. CXR, CMP, SED RATE, CBC all fine. GI consult ordered. 1/6/2021  low grade fever 99/2-99.9 gone by 1 pm.  **No new symptoms after 1/6, but lymph node is still swollen today 2/9/2021** 1/12/201 Colonoscopy and EGD, no biopsy, no concern 1/20/2021  Breast exam done at gyn office (family hx of breast cancer), ultrasound ordered of left supraclavicular lymph node 1/21/2021 Ultrasound done-results normal
Lightheadedness, mild joint pain, mild headache, muscle stiffness at injection sites, fatigue, all within 24 hours of injections.  Taking OTC Motrin for discomfort.
COVID arm; Red patch,  at injection site; Slightly raised, at injection site; Her arm hurt very bad, she wanted to cut it off; Arm felt a little heavy; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT, VACCINATION SITE REACTION, PAIN IN EXTREMITY, VACCINATION SITE ERYTHEMA, and VACCINATION SITE SWELLING in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy in 1995 and Mastectomy in 1997. Concurrent medical conditions included Neuroma and Dizziness.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced LIMB DISCOMFORT and PAIN IN EXTREMITY. On 20-Feb-2021, the patient experienced VACCINATION SITE REACTION, VACCINATION SITE ERYTHEMA, and VACCINATION SITE SWELLING. On 13-Feb-2021, LIMB DISCOMFORT had resolved. On 14-Feb-2021, PAIN IN EXTREMITY had resolved. On 26-Feb-2021, VACCINATION SITE REACTION, VACCINATION SITE ERYTHEMA, and VACCINATION SITE SWELLING had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Initial report was received 17 June 2010 via a lay press publication dated 16 June 2010 which involved six patients in the same geographical area who had been diagnosed with pertussis after they had received five previous DTaP vaccinations (lot number not reported). The information contained in the lay press publication had been retrieved from an immediate publication news released posted on 16 June 2010. This case represents one out of the six reported patients. The other patients are captured in case numbers 2010-03434, 2010-03435, 2010-03436, 2010-03437 and 2010-03438. A nine-year-old patient (gender not reported) had received five prior dose of DTaP vaccine (manufacturers, lot numbers, routes, sites and dates of administration not reported) and an unspecified amount of time after receiving their fifth dose DTaP vaccination, the patient was diagnosed with pertussis. This patient was one out of six local children who had been diagnosed with pertussis. Outcome was not reported. NO additional information was provided at the time of the report. Documents held by sender: News Release.
Experienced pure pain in both of her arms, still has pain in her hand; Cold; Pain comes down in the muscle to across her back; Uncomfortable; Cannot exercise; Pain comes down in the muscle to across her shoulder; Soreness, muscle pain, soreness is never ending, soreness goes and comes back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Experienced pure pain in both of her arms, still has pain in her hand), NASOPHARYNGITIS (Cold), BACK PAIN (Pain comes down in the muscle to across her back), DISCOMFORT (Uncomfortable) and EXERCISE TOLERANCE DECREASED (Cannot exercise) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LATANOPROST, AMLODIPINE and HYDROCHLOROTHIAZIDE for an unknown indication.    On 14-May-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 PAIN IN EXTREMITY (Experienced pure pain in both of her arms, still has pain in her hand), NASOPHARYNGITIS (Cold), BACK PAIN (Pain comes down in the muscle to across her back), DISCOMFORT (Uncomfortable), EXERCISE TOLERANCE DECREASED (Cannot exercise), ARTHRALGIA (Pain comes down in the muscle to across her shoulder) and MYALGIA (Soreness, muscle pain, soreness is never ending, soreness goes and comes back). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Experienced pure pain in both of her arms, still has pain in her hand) had not resolved and NASOPHARYNGITIS (Cold), BACK PAIN (Pain comes down in the muscle to across her back), DISCOMFORT (Uncomfortable), EXERCISE TOLERANCE DECREASED (Cannot exercise), ARTHRALGIA (Pain comes down in the muscle to across her shoulder) and MYALGIA (Soreness, muscle pain, soreness is never ending, soreness goes and comes back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-296321 (Patient Link).
Right axilla and supraclavicular lymphadenopathy; This is a literature report for the following literature source(s):  A 53-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (medically significant), 2 days after the suspect product(s) administration, outcome "unknown", described as "Right axilla and supraclavicular lymphadenopathy". The patient underwent the following laboratory tests and procedures: Positron emission tomogram: Unknown results; Sender's Comments: Based on the available information, the company considers that a causal relationship between lymphadenopathy and BNT162b2 vaccination cannot be excluded due to plausible temporal association. 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.
welt on her arm; swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (welt on her arm) and VACCINATION SITE SWELLING (swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (welt on her arm) and VACCINATION SITE SWELLING (swollen). At the time of the report, VACCINATION SITE URTICARIA (welt on her arm) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
sore and sensitive, redness at injection site, - so far has lasted  4+ days still very noticeable on Monday mid-day and shot was administered on Wednesday
Fever, chills/tremors, aches, sweats, rash rt ear, swollen eye, blisters left n right eye
Breastfeeding infant developed projectile vomiting for hours. Went to urgent card who said other breastfeeding mothers were there with sick infants with similar symptoms few days after getting vaccinated
Having allergic reaction heart burn feeling with hive reaction; Having allergic reaction heart burn feeling with hive reaction; Having allergic reaction heart burn feeling with hive reaction; This is spontaneous report received from contactable healthcare professional, the patient. A 52-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 16Mar2021 at 12:45 hours, (at the age of 52-year) as a single dose for COVID-19 immunisation. Medical history included asthma, dust mite allergy, fibroids, low iron/calcium and high platelets. It was unknown whether the patient had allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. It was reported that the patient received concomitant medications within 2 weeks of vaccination however, the medications were not reported. On 16Mar2021 at 13:00 hours, the patient had allergic reaction and heart burn feeling with hive reaction. It was unknown whether the patient received any treatment for these events. The clinical outcome of the events allergic reaction, heart burn feeling with hive reaction was unknown.   Information about lot/batch number cannot be obtained. No further information is expected.
Patient reported chest tightness about 13 minutes after vaccination.  No breathing issues, no shortness of breath.  EMS was called vitals were normal mom elected to have him taken to hospital just to make sure.  Was later reported by a family member to us that patient was released and doctors believed it to be a panic attack.
Started with a little rash on arm then blisters appeared at site of injection and spread down arm and patient states rash and blisters appeared on other arm also, has been applying hydrocortisone cream to affected area
she was experiencing itchiness all over the body; cough; runny eyes; runny nose; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient) reported for himself that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 02Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller wanted to report symptoms that she experienced after taking the 1st dose last 02Feb2021. She was experiencing itchiness all over the body, cough, runny eyes, and runny nose. She was advised not to continue to take the 2nd dose of the vaccine due to these symptoms. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.