chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A spontaneous report has been received from a Pharmacist concerning a patient. There were no reported medical history, concurrent diseases and concomitant medications. The patient received nasal FLUMIST QUADRIVALENT (intranasal) on an unknown date. On an unknown date, the patient experienced nausea and stomach pain. The outcome of the events of nausea and stomach pain was unknown. The company physician considered the events of nausea and stomach pain to be non-serious.
The parent of the pt states that about six hours after vaccine administration, they noted increased swelling (double normal size) on left leg. Also noted skin red and blotchy. Next day, skin "dark purple " with swelling and pain. Taken to the physician's office on the 3rd day.
No additional adverse events reported; Caller is nurse who reported that patient received PNEUMOV AX 23 on 11/3/2020 and then agian 11/22/2021; This spontaneous report was received from a registered nurse and refers to a 51-year-old female patient. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On 03-NOV-2020, the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 1 dose (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 22-NOV-2021, the patient was vaccinated with second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 1 dose (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (inappropriate schedule of product administration). No additional adverse events were reported (no adverse event).
Frequent falling down, dizziness, inability to walk normally, confusion,  inability to breathe , heavy chest
Approximate 4 minutes after receiving vaccines; I started getting dizzy, nauseated, cold sweat, and a headache.  There was a burning in my arm going up to my head right after the vaccine was giving for the HEP A  While at counter at the pharmacies, I had to support myself on the counter as I was having a hard time standing up.  I then left the pharmacies, and ended up on a bench outside with my head between my legs on a bench until security asked if I was OK.  Do not know how long that was.  Believe it was the HEP A (HAV) the caused the problem as a co-worker had similar but worst problem and was treated at hospital. I then tried to drive home, but was unable to drive and pull over for 15 more minutes. I then ate some food and made it home.
pt recv vax 26APR95 & shortly p/arriving home pt had 2 sz & then started having problems breathing; pt was taken to hosp & given advil & APAP & was hospitalized x 4 days; pt had t103.7 on arrival to hosp; pt is now doing well states aunt;
I noticed a significant increase in ear ringing (Tinnitus) after the shot (about 1 day after). I spoke with my my ENT about 2.5-3 weeks later to see if it would go away or if it was normal. He stated that multiple patients had similar events, but some resolved after several weeks. Unfortunately, it has been over 4 months and mine has not subsided.
Fever ? from otitis media 104. Maculo-Papular confluent red rash, conjuctivitis.
Getting progressively weak and painful in left arm (arm where received flu shot).  Hard to get arm above shoulder height without turning the arm.  Had a similar experience with flu shot 2-3 years ago (didn't report that one).
Per ER Note patient mother went into feed child at normal wake up feeding time after done feeding child vomited and started having these shaking spurts and not looking correctly. Due to this child was taken to ER. Child continued to have these movements.
Patient received a Moderna Bivalent Booster on 10/20/2022 and received a 2nd Moderna Bivalent Booster on 3/30/2023, no adverse reaction reported to health department by the patient.  Upon data entry into state immunization registry, it was noted by health department staff that patient received a 2nd bivalent booster.  This was reported to the state COVID-19 team and to the medical director of the health department.  Advised by to complete a VAERS report.
5 days after injection:  Slight swelling of both eyes and  dull headache.   Anomaly lasted 3 days.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Lot number: EL0140), on 18Jan2021 as dose 2, single (Lot number: EL3246) and on 14Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 44 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Sep2022 as dose 4 (booster), single (Lot number: A57145B) for covid-19 immunisation. The patient's relevant medical history included: "Congenital pulmonic stenosis" (unspecified if ongoing); "arrhythmia (PVCs with occasional NSVT)" (unspecified if ongoing); "mild URI induced asthma" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Erythromycin, reaction: "Drug Allergy: Erythromycin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19".  Therapeutic measures were taken as a result of vaccination failure, covid-19 included PAXLOVID from 06Sep2023 to 10Sep2023.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Huge 2 hot and hard red rash on my arm; whole upper arm, very hot; Red patch on her right eye lid; Pain in right arm muscle (injection site); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH ERYTHEMATOUS (Huge 2 hot and hard red rash on my arm), VACCINATION SITE WARMTH (whole upper arm, very hot), EYELID RASH (Red patch on her right eye lid) and VACCINATION SITE PAIN (Pain in right arm muscle (injection site)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergic to sun exposure).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain in right arm muscle (injection site)). On 27-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Huge 2 hot and hard red rash on my arm), VACCINATION SITE WARMTH (whole upper arm, very hot) and EYELID RASH (Red patch on her right eye lid). On 24-Feb-2021, VACCINATION SITE PAIN (Pain in right arm muscle (injection site)) had resolved. At the time of the report, RASH ERYTHEMATOUS (Huge 2 hot and hard red rash on my arm), VACCINATION SITE WARMTH (whole upper arm, very hot) and EYELID RASH (Red patch on her right eye lid) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   Treatment information was not provided.  The patient took Benadryl but events were getting worst not better.
Was given GARDASIL injection on 1-26-12. On 2-23-12 patient had positive pregnancy test. At time of initial injection patient stated that she had had a miscarriage in November, but apparently didn't.
Patient has metallic taste with certain foods. Patient ruled out other medications. Patient stated that the incidents would come and go, but started about 8 hours after the 2nd Moderna vaccine.
Patient complained of generalized muscle discomfort on left side of body that extended from shoulder to left leg. Patient also complained of red discoloration at site where injection was given.  Patient was referred to private MD.  Patient returned to clinic with diagnosis of cellulitis left arm and prescription for Prednisone 20mg per mouth 4 times a day for 7 days and Flextra 650 1 tablet per mouth every 6-8 hours as needed.
Patient began to feel light headed immediately after vaccine was given. She noted ringing ears and dizziness. She No epinephrine was given and she was able to walk out after ten minutes of sitting with head held forward.
By 9pm on day of vaccination, pt was feeling  pain in chest and left arm and tachycardia accompanied by numbness in both hands and injection site pain.
patient requested the PCV13 vaccine that was listed on the paperwork provided to him from his surgeon. Nurse administered this vaccine before realizing that they no longer recommends PCV13 for adults. The patient should have received PCV20. No adverse reactions or side effects occurred.
4 days after receiving the vaccine she developed a red, itchy area with bumps at the injection site of YFVAX.
Patient has been having ongoing rash in her bilateral fingertips.  These have previously improved with antibiotics, we tried a course of antibiotics over the did not improve.  She is also previously used betamethasone without any improvement.  She actually felt like the betamethasone made him worse.  During her last visit, we started her on triamcinolone and sent her for biopsy.  Biopsy showed hyperkeratotic skin with underlying epidermal spongiosis and dermal chronic inflammation with blister formation.  This is a histopathology that encompasses atopic dermatitis, contact dermatitis, and other forms of eczematous dermatitis.
Right arm swelling, golf ballsized on 12/31/2020. Redness, tenderness. By 1/1/21 swelling increased to entre arm, red, not to the touch. By 1/3/21 swelling was gone, redness still there, no pain. Muscle tenderness to the right arm still present
Nausea, Diarrhea, Headache, High fever (104), Body aches, Cold chills. Took 1000mg of Tylenol when fever started, 4mg of Zofran when nausea started, both medications helped. All symptoms stopped the following day.
Received ZOSTAVAX Inj Merck NCD: 00006-4963-41 at approximately 11:45 AM on 10/27/2017. By 2:45 PM, suffered w/onset of significant diarrhea. Induration/Erythema noted at 4:30 PM day of injection. By 8:00PM same day, onset of aches and generalized pain. On 10/28/17, 10/29/17 and 10/30/17 all symptoms continued. On 10/29/17, fever of 100.6 in the afternoon, relieved w/Acetaminophen. At this time of 9:00 on 10/30/17, joint aches, large Erythema, diarrhea and generalized feeling of debility continues.
PATIENT HAD RASH OVER THE WHOLE BODY AND SWELLING UNDER EYE AND LIP. PATIENT TOOK BENADRYL AND SWELLING WENT DOWN
Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug was not reported.   Treatment for the event was not reported.   This case was linked to MOD-2021-063893, MOD21-065883 (Patient Link).
allergic urticaria the evening of 2nd covid vaccination.  Patient has erythematous wheals to the trunk, face, neck,  head, arms, hands
Menstrual bleeding (clot) before my period is due.; This is a spontaneous report from a contactable other hcp (patient). A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0167), via an unspecified route of administration, administered in Arm Left on 28Apr2021 11:45 (34-years-old) as 1st dose, single for COVID-19 immunization. The patient medical history was not reported. Patient was not pregnant. Facility where the most recent COVID-19 vaccine was administered was Military Base. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included atorvastatin (LIPITOR); drospirenone, ethinylestradiol betadex clathrate (YAZ).  The patient experienced menstrual bleeding (clot) before her period is due on 29Apr2021 13:00 with outcome of not recovered. No treatment was given.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported event cannot be excluded. Case will be reassessed upon receipt of additional information. 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.
Complained of neck and arm pain after shot.  That night had night sweats and chills which lasted two days.  @ days later developed rash on L thorax.  Then developed nerve tingling from groin around to spine.  Then complained of feet and ankles curling and getting cramps.  Now getting cramps in thigh muscles. States she can't think straight, has to write notes to self.  She was an avid reader states she can't concentrate anymore.  Very anxious about what is going on.
bells palsy; blown up; Worst sickness; Initial information received from on 11-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional.  This case involves patient of unknown demographics who had Bell's palsy, blown up and worst sickness while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, frequency, route, administration site, lot number and expiry date were unknown) for prophylactic vaccination.  It was reported patient had worst sickness (illness), other than being blown up (unevaluable event) or having Bell's palsy (onset and latency: unknown).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events   Outcome: unknown  Seriousness criteria: medically significant for event bell's palsy and unevaluable event.; Sender's Comments: Sanofi company comment dated 11-Jan-2022: This case concerns patient of unknown demographics who had bell's palsy, unevaluable event with Influenza Vaccine (unknown manufacturer). The time to onset is not reported with the role of the vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
13APR92 mom called stated pt broke out on 12APR92; asked MD what it was when pt had other child there on 13APR92; mom stated MD said it was hives & gave pt a prescription for something-mom could not read what it was;
Narrative:  A 75yo male with PMH of Homelessness, Glaucoma, Diabetic retinopathy, DM, HTN, Insomnia, Impotence, Asthma, COPD, Hepatitis, Multiple Nodule of Lung Received first Pfizer Covid-19 Vaccine per policy and protocol, on January 19, 2021 The second Covid- 19 Vaccine per policy and protocol, on January 19, 2021 The second Covid- 19 vaccine shot on February 9, 2021 No ADE was reported Per March 31, 2021 Diabetic Ed, Nurse Tele visit documentation, the patient's niece reported "he was found unresponsive and pronounced dead on March 22, 2021"
PATIENT'S FIRST 2 COVID-19 VACCINES WERE MODERNA, AND PATIENT WAS MISTAKENLY GIVEN PFIZER FOR 3RD DOSE TODAY.
Improper preparation of thawed vial; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Improper preparation of thawed vial) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Improper preparation of thawed vial). At the time of the report, PRODUCT STORAGE ERROR (Improper preparation of thawed vial) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Client became lightheaded and nauseated 5 minutes after receiving 4 vaccinations. Put head between legs- BP 70/30. Then laid down with legs elevated BP 106/68-Feeling resolved in 5 min. Sat for another 10 min before leaving- no symptoms.
Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 5 years old male patient who was given 0.25ml of FLUZONE QUADRIVALENT instead of 0.5 ml (lot number: UT6259NA, expiry date: 31-Jul-2023, route, dose in series not reported) in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. Concomitant medication was none. It was reported that no other vaccines given on that day. This was a case of actual medication error due to vaccine underdose. It was not reported if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Hives, given steroid shot and methyprenisolone 4mg DosPak 21S
Headache, Myalgia, pain in injection site; chills; body aches Narrative:
3/25/21 To er for eval of cough, chills, shortness of breath x 2 days. States he had Covid January 2020 that left his lungs in " bad condition". Had his Johnson and Johnson Covid vaccine 2 weeks ago. Has not been drinking or eating much in the last 2 days
extreme cold temperature, excessive sweating, nausea, fever, disoriant , pain in left arm, vommiting and kidneys shut down
Onset early am itching 07/26/02. When pt awakened states she had some red raised and non-raised areas on body resembling a rash or hives. Some with whitish tops to them. Pt notified health dept by phone. After bath states some of them turned to wheals. Discomfort all over (painful), little dizzy, swelling hands, feet, skin clammy, sweaty. Unsure if temp increased. Areas also to pubic area, little trouble breathing. PC received 1pm. Referred to ER.
Macular rash started on face within 18 seconds of administration of vaccines, spread over entire body; pruritus. Epinephrine 0.2cc administered, SC, with complete symptoms stop approx. 10-15 minutes after administration.
Swollen painful lymph nodes under left arm, headache, nausea, chills, body aches
Day 1 - Day of Injection - Face broke out Got shot at 10:30am 12:30pm, face broke out with what looked like hives, but could be acne or rosacea bumps. Breakout was along side of face/jawline. Face felt hotter than usual, like sunburn. Lasted 1 hour before calming down. 2 days later, still have acne-like scabs that are healing, no further breakouts. 4pm, felt lightheaded, had headache  Day 2 - Day After Injection - Whole body issues. 8am, very sore arm around injection site, got progressively worse throughout the day, feeling hot to the touch. Red spot grew to 1.5 inch diameter. 2pm, muscles ached in back, legs, arm, lasted 16 hours until the next morning. 4pm, body felt colder than usual, needed additional blanket, despite 70 degree weather.  Day 3 - 2 Days after injection 9am, slept 10 hours. Itchy arm at injection site, redness has subsided. Most other symptoms have resolved. Throughout day - random muscle pain on injection arm, subsiding.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8737), in left arm, on 23Apr2021 as dose 2, single (Lot number: EW0175), in left arm and on 30Nov2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "primary dysthymia" (unspecified if ongoing); "migraine with aura" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION (brand: Dr), start date: 01Aug2020; PHENYLEPHRINE (brand: Wal-phed), start date: 02Jun2022, stop date: 05Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid treatment, Lot number: GC0490, from 03Jun2022 to 08Jun2022). Symptoms returned before paxlovid treatment was finished (reported as 07Jun2022 at 17:00). All doses taken on time 12-14 hours apart. Symptoms (headache, cough) returned on day 4.5 and day 5 of treatment.
Extreme shivering w/fever of 100.5, nausea, headache, large swollen red rash (painful to touch) at injection site.  Shivering and chills lasted 12 hrs. Headache, nausea, flu-like symptoms and the large red patch on arm continues (day 2).
Months later (I'm not sure of the exact timeline) overtime I noticed my hearing loss was progressing, on march 15th 2022 I went in to the eyes, nose and ear doctor to get checked out but they didn't prescribe me anything and was unaware on what the issue was. This is still an ongoing issue and I now have to get a hearing aid.
Neuropathic pain that lasts a few days and goes away.  Has occurred 4 times since injection and three different locations:  Left side of head in June and September;  Left, rear neck area in August;  Right, upper area behind hip/butt area.  No treatment.  Reminds me of the pain I had when I had shingles a few years ago, but not as painful.  My shingles pain lasted two weeks and was worse.  This lasts maybe three days but is less painful.  It has recurred though.
7-1-08 Pt received Tdap.  She felt soreness at the site and took Tylenol for 2 days.  On Sunday, July 6th she started experiencing redness at the site with swelling. She came into the clinic today 7-8-08.  Her left arm where the shot was given was red beginning at the deltoid region all the way to the elbow with quite a bit of swelling especially near the elbow.  The skin was hot to the touch.  She was complaining of pain all the way to her fingertips and in her armpit and shoulder area.  She took Advil during the night because she had trouble sleeping.  She was examined by Dr. and was given a prescription for Medrol Dose Pkt. to begin immediately.  He also recommended icing the area today.
(R) upper arm 8 x 9 cm hot red area. Fever, 101.6 Dx Cellulitis, allergic reaction given Abx.