chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine recipient reported experiencing numbness, tingling of the arm after receiving the COVID-19 vaccine. Vaccine recipient thinks that the vaccinator most likely hit a nerve when administering the vaccine. The vaccine recipient went to the emergency department for further evaluation. The vaccine recipient was monitored, felt better, and was discharged to home subsequently the same day. On Monday, I called the vaccine recipient to follow-up and they report that they no longer have the numbness or tingling.
left upper arm 11/2 by 11/2 area warm to touch, slight swelling and redness
This spontaneous prospective pregnancy report was received from the patient's husband regarding his wife of unknown age. The patient's current conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9. The patient's last menstrual period (LMP) was approximately 16-MAY-2016 (reported as almost a half month). The patient's estimated date of delivery (EDD) was 20-FEB-2017. The outcome of the pregnancy was unknown. No further adverse event (AE) information was provided. Product quality complaint (PQC) was not involved. Additional information is not expected, as the contact details were not provided.
Pain (tingling/burning sensations) started about six hours after injection, it continued to get worse over next several days.  Pain went from ear to finger tips, including shoulder and chest.  Her personal MD thinks the vaccination triggered a shingles reaction, the patient did have a few blisters pop up on shoulder
My heart rate has been elevated on a continual basis since getting the 2nd dose.  I have shortness of breath, constant jitters and an erratic heart beat (skips beats).   It is constant and does NOT go away.  I have not ingested any stimulants (coffee, food, medicine, etc) of any kind over the past month.
syncope 2 hours after his vaccination. he felt nauseous and fainted. LOC lasted 30 seconds. no palpitations, dizziness, diaphoresis, chest pain. no seizure activity noted, but states he had urinary and fecal incontinence.
Pt recvd Engerix-B on 5/10/95, 6/26/95, and 1/25/96. He also recvd DPT (Lederle Labs) on 6/26/95, 8/22/95, 10/26/95, 1/25/96 and 10/28/96. He recvd HIB (Lederle Labs) 6/26/95, 8/22/95, 10/26/95 and 10/28/96. He received oral poliomyelitis vaccine (Lederle Labs) 6/26/95, 8/22/95, and 10/28/96. He recvd MMR (Merck) 7/25/96 and varicella virus vax (Merck) 4/29/96. The pt's attorney alleged that "shortly before his 21-month check-up, pt began to display symptoms of neurological damage consistent with mercury poisoning. The symptoms included, without limitation, regression of his language skills, engaging in repetitive behaviors, suffering from diminished cognitive ability, and becoming socially withdrawn. Pt received and is still receiving medical treatment in an effort to remove mercury from his body. As mercury levels in his body have decreased, the plaintiffs have noted modest improvement in symptoms." The attorney alleged that each symptoms was severe in intensity. The attorney also alleged that each dose of every vaccine administered was the source of the mercury. This report of mercury poisoning is considered GSK medically serious.
This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 30Mar2021 at 14:00 (at the age of 32-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have a history of allergies to medications, food, or other products. Concomitant medications included bupropion hydrochloride (BUPROPION HCL XL). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021, after 3 days of vaccination, the patient experienced headache, diarrhea, abdominal cramping, hot flashes, and fatigue without fever which had lasted 4 days so far and had not gotten better. Adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events experienced headache, diarrhea, abdominal cramping, hot flashes, and fatigue was not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sat 11/20/21: Developed 1 large hive/wheal below the right buttock around 9 pm. was gone upon awakening next day. Sunday 11/21/21: at night (around8-9pm)- felt itchy & had minimal small hives scattered on mostly my back, neck, & occipital area of head itchy- took Zyrtec 10mg with improvement. Monday 11/22/21: woke up without symptoms. developed same symptoms, as previous night, around 8pm, slightly worse than 11/21/21. Again took zyrtec 10mg. Tues 11/23: woke up 8am with slight improvement in symptoms. Throughout the day had small hives & tiny bumps appearing, disappearing, and re-appearing on random places (i.e. forehead, stomach, arms, back, legs, knees, elbows) - also appeared to have scratch like marks and some linear type wheals. got worse in evening 6pm. improved w/ Benadryl then worse 2 hrs later. also felt burning, warm, reddened ears and behind ears. Wed 11/24: woke up 8am and again felt same feeling behind ears & had 1 or 2 tiny hive-like bumps outside each eye. Took Zyrtec 10 mg &  famotidine 20 mg with improvement in symptoms.  Thurs 11/25: symptoms improved. had intermittent red marks on varied locations of body, occasionally itchy, and upon scratching got worse and more inflamed and left red slightly raised scratch marks lasting <2 hours. symptoms improved slightly with Zyrtec 10 mg &  famotidine 20 mg . Fri 11/26: again had intermittent red marks on varied locations of body, occasionally itchy, and upon scratching got worse and left red scratch marks lasting <2 hours. symptoms improved with Xyzal 5 mg &  famotidine 20 mg . Between 11/27 to present: have continued to have intermittent red marks on varied locations of body (arms, legs, palms, top of feet, back, stomach), itchy, and upon scratching gets worse, feels warm & burning. red scratch marks vary in size, are slightly raised, and last <2 hours at a time.  diagnosed w/ dermatographia 12/2/21 by an allergist. taking  Xyzal 5 mg every night &  famotidine 20 mg every afternoon with slight improvement in symptoms each day. symptoms are always worse at night.
Administration of Shingrix to patient suspected of having shingles; This case was reported by a other health professional via call center representative and described the occurrence of off label use in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 27PA5, expiry date 3rd February 2023) for prophylaxis.   The patient's past medical history included feeling unwell (feeling kind of yucky prior to vaccination) and tiredness (felling tired prior to vaccination). Concurrent medical conditions included shingles (suspected of having a shingles before vaccination, no signs or symptoms of clinical definite shingles rash, blisters, pain).   On 9th August 2021, the patient received Shingrix. On 9th August 2021, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were provided as follows: The pharmacy Intern reported that, the administration of Shingrix to patient suspected of having shingles, which led to off label use. The titer testing was negative but was discovered to be the incorrect testing.  The patient experienced feeling kind of yucky, tired prior to vaccination, no signs or symptoms of clinical definite shingles (rash, blisters, pain) noted per health care professional. The reporter consented to follow up.
57 yo F with multiple medical issues including asthma, hyperthyroidism, rhinitis was given Pneumovax (lot #J005071 - Merck & Co., exp 1/19/15) 0.5ml SC and Tdap (lot # 4T7E4 - GSK; exp 3/18/16) 0.5ml IM in the right arm on 12/2/13. Following injection, pt states she had pain, swelling and itching at the site. Symptoms worsened over next two days until pt reported swollen, red and painful right arm to MD on 12/5. Pt mentioned erythema tracks from mid humerus to mid radius. Pt was seen again in clinic 12/5 and diagnosed with cellulitis. Reported fever, chill and malaise. Cefalexin 1000mg po BID prescribed x 10 days.
Patient received COVID vaccine at 2:12 pm and she was observed for 15 minutes. Pt denied any complaints during the 15 minutes but when she was about to leave she complained of dizziness. Vital signs stable except mild tachy HR 106, O2 sat 98%, BP 118/74. She also c/o nausea patient was given water to drink, feet were elevated and she started to feel better. Pt constantly c/o dizziness and nausea associated with headache. symptoms got worse over time. 911 was activated at 15:38. EMS arrived at 15:54 patient was taken to hospital for further evaluation. Pt left at 16:04.
Less than 24 hours after injection, I experienced e - Extreme headache, chest pains, high fever and frigid coldness; fainting and disorientation.  My son carried me to bed and massaged Vicks on my chest. He covered me with a warm blanket and prayed for the intervention into my plight.  Now I have ongoing headaches, great pressure on my chest, weakness, spasm and extreme fatigue. Pain, numbness and stiffness throughout whole body.
Headache, Arthralgia & Fever Narrative:  employee c/o lingering sore throat, headache, chills, sweating, sinus pressure as of 2/3/21
Starting on 8/15-8/16/07 had flu type symptoms. Generalized aches and pains with nausea and fever. Left shoulder down to the elbow was red, not painful, no edema. Over the counter Advil.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Tachycardia-Mild, Additional Details: Patient fainted within 5 min of vaccine.  We checked her BP and HR and had her sit so we could monitor her. She did not want to be seen by emergency dept or doctor. We monitored her for 15 min. She said she felt fine and called a friend to pick her up. We monitored her an addtional 10 min. and took down her phone number to check on her tonight.
elevated liver and kidney function; Elevated white blood count; fever; elevated liver and kidney function; Covid vaccine related issues; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4165037-00.  A 52-year-old female patient received BNT162B2 (BNT162B2), intramuscular, administration date 30Oct2021 (also reported as 31Oct2021) (Batch/Lot number: unknown) at the age of 52 years as dose 1, single for covid-19 immunization; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for Crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RENAL IMPAIRMENT (medically significant), LIVER FUNCTION TEST INCREASED (non-serious) all with onset 2021, outcome "unknown" and all described as "elevated liver and kidney function"; WHITE BLOOD CELL COUNT INCREASED (non-serious) with onset 2021, outcome "unknown", described as "Elevated white blood count"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; VACCINATION COMPLICATION (non-serious) with onset 2021, outcome "unknown", described as "Covid vaccine related issues". The patient underwent the following laboratory tests and procedures: investigation: (2021) elevated; liver function test: (2021) elevated/increased; white blood cell count: (2021) elevated/increased. The action taken for adalimumab was unknown. Causality of events to adalimumab was not reported. Causality of events by the reporter to BNT162B2 was probable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out. 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.
Mother intended for daughter to have HPV#2 vaccine and patient received 1st dose of Bexsero.
The day after the vaccine was recieved, on 2/2/11 I felt itching at the site of the injection. Rt. arm. The following day the area around the site of injection went from a quartersize bright red area to approx. the size of my fist.  This area was mostly bright red and gradually pinkish down the back part of the arm.  On 2/3 visited the primary physician and was given Keflex to take for 7 days.
injection site itching; injection site redness; injection site swelling; injection site warmth; injection site tenderness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Feb2021 (Lot number: EN6202) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression and anxiety" (unspecified if ongoing); "Depression and anxiety" (unspecified if ongoing); "possible allergies to gluten" (unspecified if ongoing); "dairy" (unspecified if ongoing); "adhesives" (unspecified if ongoing). Concomitant medication(s) included: VIENVA. Vaccination history included: Bnt162b2 (Dose 1, single at 10:00, administered on Left arm, Lot number: EL9264), administration date: 06Feb2021, when the patient was 25 years old, for Covid-19 immunisation, reaction(s): "headache", "fatigue". The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 28Feb2021, outcome "not recovered", described as "injection site itching"; VACCINATION SITE ERYTHEMA (non-serious) with onset 28Feb2021, outcome "not recovered", described as "injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset 28Feb2021, outcome "not recovered", described as "injection site swelling"; VACCINATION SITE WARMTH (non-serious) with onset 28Feb2021, outcome "not recovered", described as "injection site warmth"; VACCINATION SITE PAIN (non-serious) with onset 28Feb2021, outcome "not recovered", described as "injection site tenderness". Therapeutic measures were not taken as a result of vaccination site pruritus, vaccination site erythema, vaccination site swelling, vaccination site warmth, vaccination site pain.   No follow-up attempts are possible. No further information is expected.
Information has been received from a pharmacist and a nurse concerning a 65 year old female patient with allergic reaction to penicillin, erythromycin and sulfonamide and a history of previous vaccination with PNEUMOVAX (date not specified) who was vaccinated IM with a dose of PNEUMOVAX lot # 662100/0742X. Concomitant therapy included FLUZONE. The reporter reported that the patient developed soreness. warmth and swelling at the injection site. She also developed nausea and body aches on 02-OCT-2008. She was given KENALOG 60 mg IM on 02-OCT-2008 because she was presented with swelling and pain from her elbow to her shoulder. No other details reported at this time. The patient had not recovered. A standard lot check was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center and was released. Additional information has been requested.
I developed hives on the insides of both of my lower legs. This developed approximately 30 hours after I was vaccinated.
possible M/I chest pain Narrative:  On 1/29/20 patient taken to local hospital via ems then was transferred to second hospital to rule M/I
Nausea, vomiting, body aches, chills, general yucky/tired feeling.  I spent most of the first three days in bed.  It took 8 days before the symptoms totally went away.  I want to stay up to date on my covid vaccinations, but I can't go through these extreme symptoms and spend a week in bed again.
1st IM Pfizer vaccination on 4-8-21, no issues until awakened at 4am on 4-13-21 with severe dizziness-room spinning, very mild nausea, still mild dizziness until midafternoon - no other issues until 4-18-21 at 5 am, once again awakened by severe dizziness, room spinning out of control- incapacitating dizziness continued well into next 12 hours of the day accompanied by severe nausea and headache, nausea improved with ondansetron and dizziness improved with meclizine after hours of not being able to ambulate.
Initial information received on 01-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 55-years-old female patient who reported that the pain in her left arm from the injection is so severe that when she lifts that arm it takes her breath away, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient described herself as healthy and a person who exercises with lifting weights daily. No other vaccine was given on that day. On 18-Jan-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number C5585BA (Expiry date 06-Mar-2021) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious pain in her left arm (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This is also a case of actual medication error due to wrong vaccine administered. It was reported that the patient did not want a Tdap vaccine and had visited the office for a Td vaccine. The office did not have any Td on hand and insisted on giving her Tdap. The consumer worried that she received the correct vaccine. Event details: Caller stated she was not able to use her arm for 2 months after receiving TDAP. The caller stated her arm still hurts when she is trying to use it. There was no visible bruise, but the pain has been so bad that she was very close to visiting the ER. (Other relevant tests included no lab data). Final diagnosis was severe pain in her left arm. It was not reported if the patient received a corrective treatment. The outcome of the event was considered not recovered at the time of report. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
diarrhea; mental fog like severe symptoms; fever (100+ degrees Fahrenheit); nausea; This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA (diarrhea), FEELING ABNORMAL (mental fog like severe symptoms), PYREXIA (fever (100+ degrees Fahrenheit)) and NAUSEA (nausea) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21ASJM-PMG and 027B21A) for COVID-19 vaccination.     The patient's past medical history included Surgery.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced DIARRHOEA (diarrhea), FEELING ABNORMAL (mental fog like severe symptoms), PYREXIA (fever (100+ degrees Fahrenheit)) and NAUSEA (nausea). The patient was treated with OXYCODONE at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), FEELING ABNORMAL (mental fog like severe symptoms), PYREXIA (fever (100+ degrees Fahrenheit)) and NAUSEA (nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Inappropriate dilution of medication/vial was diluted with 0.18 ml instead of 1.8 ml; it was not diluted properly - got a high dose; injection site/systemic AEs; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received dose 1 Pfizer COVID-19 vaccine on 02Apr2021, and the vaccine wasn't diluted properly, the patient got a high dose: vial was diluted with 0.18 ml instead of 1.8 ml and 0.3 mL was administered to patient. The patient experienced injection site/systemic AEs in Apr2021. The pharmacist followed up with the patient several days later and the injection site/systemic AEs were resolved in Apr2021. No treatment information was reported. The patient was due to dose 2 and he wanted to know if it was ok to administer it at the recommended interval.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a healthcare worker referring to a 6 month old male patient who was born a preemie at 23 weeks gestation. On 18-FEB-2016, the patient was inadvertently vaccinated with the first dose of ROTATEQ, oral. No adverse effects reported. Additional information is not expected as the reporters do not want to be contacted regarding this report.
11/29/22 1607: experienced burning at site of injection in left deltoid; evening of injection, noticed swelling at site of injection and pain at left shoulder join; employee took tylenol and ibuprofen the night of injection; also applied heat packs to injection site
I have been having sinus flare ups and fatigue, a little muscle pain sometimes. when these things happen I take COVID-19 test but there negative, I get these symptoms like I have COVID but I don't. When I go to the doctor they just say its just an infection and they will give me either a shot or antibiotics or a nasal spray.
severe injection site pain, starting day of injection and lasting 48 hours severe headache and neckache, staring evening of injection and lasting 72 hours, intermittent night sweats, approximately 60 hours after injection  starting the evening after injection, pain increased in injection site.  In middle of night, woken up by severe headache pain.  Treated with 600mg ibuprophen and 2.5 mg Zomig.  Throughout next day, injection site and headache pain present, but less worse than night, treated with ibuprofen.  Second evening (approx 36 hours after injection), pain again severe in the middle of the night, woke up, treated with 600 mg ibuprofen and 2.5 mg Zomig.  Woke up sweating, but feeling better.  Symptoms gradually resolved over the next day.