chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; injection site pain; loss of balance; mental fog; congestion; breathing difficulty; lethargy; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 02Apr2021 at 08:15 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included COPD and COVID-19. Concomitant medications included atorvastatin calcium (LIPITOR) and fluticasone propionate, salmeterol xinafoate (ADVAIR) both for an unknown indication and from an unknown date. The patient previously received levaquin for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 16:00, the patient experienced headache, injection site pain, loss of balance, mental fog, congestion, breathing difficulty and lethargy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department, or urgent care. No therapeutic measures were taken as a result of events. The clinical outcomes of the events headache, injection site pain, loss of balance, mental fog, congestion, breathing difficulty and lethargy were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
L Axillary lump noted in arm on 9-20-09. Then developed fatigue, lethargy, HA, nausea. Seen at urgent care @ 830PM ON 9-20-09. Woke at 3AM on 9-21-9 with sweats. Seen and f/u here at 11:30 PM. Still with slight HA and fullness L axilla
Headache, Anaphylaxis, CoughWheeze, NauseaVomiting, lips and tongue swelling Narrative: employee received the 2nd COVID vaccine, began to have lip and tongue swelling that required injection of Triamcinolone 40mg/ml
Severe local reaction after 24 hrs. Urticarial rash after 2-3 days.
child was given an IPOL injection that had been punctured/ no AE; Initial information was received on 10-Dec-2021 regarding an unsolicited valid non-serious case received from a Physician via Agency (Reference number- 00893353.  This case involves a nine-year-old male patient who was given IPV (VERO) [IPOL] injection that had been punctured with no adverse event (Poor quality product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE, DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  On 10-Dec-2021, the patient received 0.5 mL (total) dose of suspect IPV (VERO) [lot T1E872M and expiry date 10-Oct-2022] via subcutaneous route in left arm for prophylactic vaccination.  It was reported "Nurse calling to report that a child was given an IPOL injection today from a MDV that had been punctured on 14Oct2021. Caller is wanting to know if the child needs another dose".  Product used: Used. First time product used: No. Still using product: No.  It was a case of actual medication error due to Deteriorated drug administered (latency on the same day).  At the time of report, no adverse event reported.  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 the 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.
Extreme exacerbation of existing joint pain in right hip, lower back and right shoulder approximately 10 days after initial vaccination on 15Mar2021.; This is a spontaneous report from a contactable consumer, the patient. A 62-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 left arm on 15Mar2021 at 11:30 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, joint pain in right hip, lower back and right shoulder and COVID-19 (which was diagnosed prior to the vaccination). Concomitant medications included levothyroxine sodium (SYNTHROID) from an unknown date for an unknown indication. The patient previously took INDOCIN for an unspecified indication and experienced drug allergy. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021, approximately 10 days after initial vaccination, the patient experienced extreme exacerbation of existing joint pain in right hip, lower back and right shoulder. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room or department or urgent care. The patient had self-administered ALEVE as a treatment for the reported event. The clinical outcome of the event joint pain was not recovered at the time of this report.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of GARDASIL. On an unknown date, the patent inadvertently received their second dose of GARDASIL 0.5 ml, intramuscular, outside the prescribing information. No adverse effects was reported. Additional information has been requested.
Patient admitted as inpatient on 12/3 due to acute on chronic respiratory failure with hypoxia and hypercapnia secondary to COVID pneumonia. Patient was tested for COVID-19 and was positive on 12/3.
Initial report was received from a healthcare professional on 04 January 2012. A 52-year-old female patient had received an intramuscular (IM) injection of FLUZONE; lot number UH454AD (site of administration was not reported) on 30 December 2011. On an unspecified date two to three days after vaccination, the patient developed red, scaly, dry and itchy area at injection site and surrounding area; stated better than it was. No further information was available at the time of the report. The patient outcome was reported as not recovered/not resolved. Follow-up information was received from a health care professional on 23 February 2012. The patient recovered. No further information was available at the time of the report. The patient's outcome was recovered. Follow up information received on 27 April 2012: The onset of the adverse event was reported as 02 Jan 2012. The corrective treatments included cool compress in interim and BENADRYL for itch. Follow up information received on 15 June 2012: The patient resolved incompletely. Itch resolved however the area of reaction was still slightly visible. Updated the outcome for vaccination site exfoliation and erythema from recovered to recovering. Documents held by sender: none.
Dissy, pale, nausea, temp 99.8, was at 97, weak, tired & stuffy head.
The first dose of the vaccine went fairly well aside from fever, muscle aches, and pain in the left arm at the injection site. The second dose was reportedly worse. The fever ranged from 104.8 degrees Fahrenheit as a high and 102 degrees Fahrenheit being low, which receded after 3 days of care. In addition, chest pains and heart pain started at 8:00pm the day of the vaccination which was completed at 11:15am. Pain at the injection site and overall body muscle aches lasted for 3 days.   The heart/chest pains have yet to recede. Instead it is occurring more frequently in ?bursts? of pain with a constant aching sensation.
took a Pfizer Vaccine as their first round. They had two subsequent rounds and they did contract COVID within the last 24 hours.; contract COVID within the last 24 hours; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "took a Pfizer Vaccine as their first round. They had two subsequent rounds and they did contract COVID within the last 24 hours."; COVID-19 (medically significant), outcome "unknown", described as "contract COVID within the last 24 hours". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Unknown results, notes: they did contract COVID.  Clinical course: Reporter stated that one of my family members (consumer) took a Pfizer vaccine as their first round. They had two subsequent rounds and they did contract Covid within the last 24 hours. I do not know if we were supposed to report that because I know there are a lot of variants out there that are being covered by the vaccine and it was the very first one that this person took versus taking two additional ones after that, the second round and the Booster. It was the Pfizer I believe it was just that first round of the Pfizer Covid-19 Vaccine, yes, the first round, I do not know what that's called. Confirmed as Pfizer Covid-19 Vaccine. No, everything has been fine and hopefully but I thought if we were supposed to report that one of these new variants overcame, I do not even know like I said after three rounds, the other two rounds I do not know if they were Pfizer drugs or if they were Moderna or anybody else.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case number PHEH2011US07000 is an initial spontaneous report received from a nurse on 14 Oct 2011: This report refers to an adult female patient. She was vaccinated with MENVEO (batch number A10053), 0.5 ml, intramuscularly, on 15 Aug 2011. Minutes after vaccination, she experienced syncope. Episode was short and event was resolved.
Expired vaccine administered to 11 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients). On 16-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Concomitant medications details were not reported by the reporter.Treatment details was not reported by the reporter.Company comment : This is a case of expired product administered for this 57-year-old male patient. No adverse events were reported. The benefit-risk relationship of mRNA-1273  vaccine is not affected by this report. Sender's Comments: This is a case of expired product administered for this 57-year-old male patient. No adverse events were reported. The benefit-risk relationship of mRNA-1273  vaccine is not affected by this report.
Vertigo, loss of consciousness, vomiting, diarrhea, sweats, inability to control limbs to stand or walk, altered vision (white picasso slides),
Information has been received from an RN concerning a 4 year old female, who on 5/7/01, was vaccinated with MMRII, in the leg. Concomitant therapy, also given on 5/7/01, included DPT and poliovirus vaccine. It was also reported that the pt had received her varicella virus vaccine live, on approx. 6/27/97, in the pt's left leg in which she received the MMRII, DPT, tuberculin purified protein derivative and poliovirus vaccinations became hot and swollen. On the next day, the pt's symptoms worsened and she was dx'd with cellulitis. The child was treated with cephalexin (Keflex) and subsequently, recovered from the cellulitis. On approx. 5/18/01, the pt developed a "very severe case of chicken pox with approx. 50 lesions, on the left leg around the injection site". Upon internal review the cellulitis is considered an "Other Medical Event". Additional information has been requested. F/U It was further reported that on 5/10/01 she was seen again and that the area was more extensive. As of 5/17/01, the cellulitis was resolving. Subsequently on 5/24/01 the pt recovered. It was also reported that the pt had rec'd one dose of varicella virus vaccine live (site unknown) at one yr of age on approximately 6/27/97 and on approximately 5/17/01 developed chicken pox (WAES01091138). Upon internal review the cellulitis was considered to be an other important medical event. No further info is expected. F/U states: Information has been received from a physician and an RN concerning her 4 year old white female, family member, with an allergy to sulfa, no illness at the time of vaccination and reported to be in "otherwise good health" who on 5/7/01 (also reported as 5/9/01) was vaccinated with the 2nd dose of MMRII, SC, in the right thigh (lot 637433/0149L). Concomitant therapy, that day, included the 5th dose of alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Tripedia), IM, in the left thigh (lot V02998A), 1 dose of tuberculin purified protein derivative (Tubersol) (site not reported) and the 4th dose of poliovirus vaccine (IPOL), SC, in the left thigh (lot R1437). It was noted that the child was being vaccinated for kindergarten. Subsequently, on approx. 5/7/01 (also reported as 5/10/01), the pt's left leg in which she received Tripedia and IPOL became hot and swollen. On the next day, the pt's symptoms worsened. That morning, on 5/8/01, she had redness and swelling of the left thigh, was seen in urgent care and was dx'd with cellulitis. The child was treated with cephalexin (Keflex). It was further reported that on 5/10/01, she was "seen again" and that the area was more extensive. As of 5/17/01, the cellulitis was resolving. Subsequently, on 5/24/01, the pt recovered. It was also reported that the pt had received 1 dose of varicella virus vaccine live (site unkown) at 1 year of age, on approx. 6/27/97 and on approx. 5/17/01, developed chicken pox (WAES01091138). No further info is expected.
Scab at the injection site; Left arm is red at the injection site; Slightly raised at the injection site; Left arm is swollen at the injection site; extend down 3 inches; Left arm became itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Left arm became itchy), VACCINATION SITE SCAB (Scab at the injection site), VACCINATION SITE SWELLING (Left arm is swollen at the injection site; extend down 3 inches), VACCINATION SITE ERYTHEMA (Left arm is red at the injection site) and VACCINATION SITE SWELLING (Slightly raised at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient has no known medication allergies. The patient had high cholesterol.  The patient's past medical history included Memory impairment. Concurrent medical conditions included Hypothyroidism and Cholesterol high. Concomitant products included LEVOTHYROXINE, VITAMIN D3 and IRON for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PRURITUS (Left arm became itchy). On 18-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Left arm is swollen at the injection site; extend down 3 inches). On an unknown date, the patient experienced VACCINATION SITE SCAB (Scab at the injection site), VACCINATION SITE ERYTHEMA (Left arm is red at the injection site) and VACCINATION SITE SWELLING (Slightly raised at the injection site). At the time of the report, PRURITUS (Left arm became itchy), VACCINATION SITE SCAB (Scab at the injection site), VACCINATION SITE SWELLING (Left arm is swollen at the injection site; extend down 3 inches), VACCINATION SITE ERYTHEMA (Left arm is red at the injection site) and VACCINATION SITE SWELLING (Slightly raised at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication were not reported/unknown.  The patient reported that she might have scratched the area to cause the scab. The patient had not informed her HCP of the events.  Patient also deny for further follow-up as per the Telephone contact report.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up information received on 25-JUN-2021 and contains no new information.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 20-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1802USA001558:
Sat down, felt hot (left coat on), felt light headed, nauseated & nervous.  Took coat off: felt better.  Lasted 10 min
itching at the injection site; mild ache at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE PAIN (mild ache at the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (mild ache at the injection site). On 11-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site). At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE PAIN (mild ache at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information provided.
On January 29 my lip randomly started swelling. I was laying in bed no food or drink for over an hour. No medications, new body washes soups etc. no new laundry detergent. Thought it was random until my lip once again started swelling on  2/1 in the morning while brushing my teeth (nothing new about routine) it then once again started to swell at work on 2/4 once again no food or drink or change in anything, and lastly began again last night 2/5 while laying in bed. Each time has been different locations of the lips has not spread further and has be variant in symptom intensity. One case only lasting minutes and 2 lasting up to 24 hours. Might not be related to vaccine but I?ve never had any allergies before and this began after, so for the sake of research decided to report.
Failure of VanishPoint Syringe Lot# G211019. No issues with drawing up vaccine. When removing needle from the deltoid the nurse  felt resistance. She heard a click once administration of medication was completed.  When  the needle was removed, the medication leaked out of the patients arm and out from the end of the needle. Patient notified. Provider contacted and advise to repeat full dose. Full dose administered.
Pt reported an outbreak of genital herpes after receiving vaccine. Said she had not had an outbreak in years and felt it was the vaccine.
This spontaneous report as received from a other refers to a 58 year old male patient. The patient's medical history included transfusion. On 06-OCT-2009 the patient was vaccinated with ZOSTAVAX lot # M041086, .65 ml, subcutaneous in the right arm for prophylaxis. Concomitant therapies included sterile diluent (MERCK). On 06-OCT-2009, 1 day after onset of therapy the patient experienced inappropriate schedule of drug administration. The outcome of inappropriate schedule of drug administration is unknown. The reporter considered inappropriate schedule of drug administration to be not related to ZOSTAVAX.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with expired ZOSTAVAX (Lot # 665528/0710Z, exp date 28-APR-2011) on 17-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Anthrax vaccine was administered on 23Sep2004. No reaction was noted 30 minutes after immunization. On the morning of 24Sep, the patient noticed a red, hot, painful plaque around the site.
Bell's Palsey.  Pt came into the pharmacy on 06/20/2021 to pick up a maintenance medication  and stated that he was diagnosed with Bell's Palsey back in April affecting right facial hemisphere. Pt stated the physician told the pt to tell the pharmacy to report incident.
Bilateral upper and lower extremity paralysis, jaw clenching, dystonic contracting of bilateral upper and lower extremities. Urinary retention.
Developed red papule on left lower eyelid and within one hour developed multiple. 10-12 red papules on nape of  neck, left thigh, right thigh, abdomen. Left and right upper arm lesion 1 mm clear almost vesicle like center surrounded by 2-3 mm red base.
Swelling right jaw and face over 12 hours.  Somewhat tender.  No systemic symptoms.  Exam confirmed normal temperature, right parotitis. A strep test was negative.
AT ONE WEEK AFTER SHOT. RED RASH AT INJECTION SITE WITH LARGE HARD LUMP UNDERNEATH, ITCHING, INFLAMED.
PT received vaccine at 1020, and remained on site for almost 30 minutes before leaving.  While driving home PT started to feel a tightness in her throat and that her face felt warm and swollen.  PT returned to vaccination site.  PT showed no sign of difficulty breathing and was able to speak in complete sentences.    BP: 110/70 Pul: 58 O2: 95 Temp: 97.6  PT was administered 5ml of antihistamine liquid medicine and was observed.  After observation for 5 minutes, PT stated that she was feeling lots better and that the medication was working.  Gave advice to follow up with PCP or get to hospital if condition worsens.  Advised to inform medical team at her next scheduled vaccination of her reaction.