chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.   Reporter did not allow further contact
This spontaneous report was received from a healthcare professional and refers to an unspecified patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions or concomitant therapies provided. On an unknown date, the patient was vaccinated with a dose of RECOMBIVAX HB (lot #, expiration date, site, dose and route of administration were not reported). On an unknown date, the patient experienced an unspecified averse event. The outcome of the event was unknown. The relatedness between the event and RECOMBIVAX HB was not reported. Additional information is not expected due to lack of the reporter's contact details.
the day deltoid area was sore;the next day pain traveled to anterior shoulder joint pain would wake up noc;shoulder pain (bursitis) has cont although is gradually improving;
I went to  for a tetanus vaccine, but the pharmacist administered the COVID-19 Pfizer vaccine. He then administered the Tdap Boostrix vaccine in the other arm. I am fully vaccinated with the COVID-19 Moderna vaccine, and waited to get the tetanus vaccine until after I was fully vaccinated, but now have received a dose of the Pfizer vaccine and the tetanus vaccine on the same day.
couldn't get out of bed; not able to function like she normally does, couldn't move; couldn't even control her bladder; can't seem to get back on her feet; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 19Sep2021 (at the age of 64-years) (Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD) diagnosed in 2010 or 2011, cancer, severely immunocompromised, severely allergic to latex; patient also had surgery for cancer and chemo which is finally over. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. No flu prior to vaccination. In Sep2021, the patient couldn't get out of bed; not able to function like she normally does, couldn't move; couldn't even control her bladder and had to have disposal underwear just to handle things, and can't seem to get back on her feet. Every time she thinks she's getting better, she has a bad air quality day and sets her back, it doesn't put her back in bed per se but it puts her where she's not able to function like she normally does and that really affects her COPD (for clarification). She confirmed all symptoms were disabling, she couldn't even get out of bed. She wanted to know how long the symptoms would last from the Pfizer Covid 19 Vaccine. Outcome of the events was unknown.  Relatedness of drug to all reactions/events: Source of assessment: Primary Source Reporter; Method of assessment: Global Introspection; Drug result: Related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As per available information, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 54-year-old male patient received BNT162b2 (BNT162B2), on 21Jul2021 at 09:00 as dose 1, single (Lot number: FC3183), in left arm and on 20Aug2021 at 09:30 as dose 2, single (Lot number: FA7484) at the age of 53 years, in left arm for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21May2022, outcome "unknown" and all described as "21May2022 Nasal swab: positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test (21May2022) Positive. Clinical course: The patient did not receive any other vaccine in four weeks. The patient did not had Covid prior vaccination. No follow-up attempts are possible. No further information is expected.
4 month old was given MENQUADFI/administration to a child younger than indicated age range with no other reported adverse event; Initial information received on 10-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 4 months old and unknown gender patient who was given menquadfi/administration to a child younger than indicated age range with no other reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect meningococcal a-c-y-w135 (t conj) vaccine (dose, route, strength, formulation, frequency, batch lot number and expiry date: unknown) in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event 4 month old was given menquadfi/administration to a child younger than indicated age range with no other reported adverse event (product use issue) (unknown latency) following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (product use issue).  At time of reporting, the outcome was Unknown for the product use issue.   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.
Patient stated she experienced shoulder pain and swelling in her neck which began on day 2 of vaccination. She stated the pain was most severe on day 3 and 4 which required her to take an antispasmotic that had previously been prescribed to her for her back. Patient did not see a physician for this complaint.Patient stated this condition lasted through day 14 when her scab fell off.
Information was received on 26-MAY-2017 regarding a case in litigation concerning a male (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On or about 13-JUN-2013 the patient received a dose of ZOSTAVAX (lot # and dose not specified) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-AUG-2016 the patient was treated for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed acyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Headache, Fever,  FATIGUE, MUSCLE ACHES, DIARRHEA, INJECTION SITE ARMPIT SWELLING  Narrative:  EMPLOYEE STATES: EXPERIENCED SIDE EFFECTS FOR 2 DAYS FATIGUE, HEADACHE, MUSCHLE ACHES, FEVER UP TO 102 F, DIARRHEA 4/26 AND 4/27 SWELLING OF ARM PIT OF INJECTION SITE ARM.
dose that had expired on 31-Oct-2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA462A, expiry date 31st October 2021) for prophylaxis.   On 3rd March 2022, the patient received Menveo. On 3rd March 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received an expired dose of Menveo, which led to expired vaccine used.
6/25/03 pt examined and determined sx not related to oral Typhoid and represcribed two additional capsule to complete the series.
Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration on 14Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 14Mar2021, after getting the first dose of vaccine in the morning, the patient experienced tinnitus in the evening. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
This infants left leg had swelling, redness, and heat. Tylenol and Benadryl.
Tested positive for Covid; Tested positive for Covid; booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 22 year-old female patient received bnt162b2 (BNT162B2), administration date 29Nov2021 (Batch/Lot number: unknown) at the age of 22 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: prior to being eligible for vaccine. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2), for covid-19 immunization; Bnt162b2 (Dose 1), for covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 29Nov2021, outcome "unknown", described as "booster dose"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "unknown" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Dec2021) positive. The patient was fully vaccinated (all three doses) and she had covid prior to being eligible for vaccine. Today she tested positive for covid again. She has no known underlying conditions. Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Parents completed original consent form on 03/15/2021 stating birth date was written for age as 16.  His correct birthdate is one year younger and he is actually 15.  Patient presented to get his second shot and completed his consent form, writing his correct date of birth and age.  Patient was refused second shot due to being 15 years old.  Patient had no reported adverse reactions to first Pfizer vaccine on 3/15/2021.
Left upper extremity erythema, swelling and induration without fever 24 hours status post vaccine administration of Hep A and DTaP to left arm. Treated with Ibuprofen and Benadryl and close observation.
Vaxs given 7am-Within 8 hrs pt experienced severe nausea,dizziness & fever of 101,MD RX:  Phenergan & APAP. MD recommended not to cont the series
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. Pharmacist reported that in 1999, the patient was vaccinated with first dose of (Oka/Merck) VARIVAX (dose, strength, frequency, lot number and expiration date were not reported) and on 26-JUN-2014, the patient was vaccinated with second dose of (Oka/Merck) VARIVAX 0.65 ml, subcutaneous (strength, lot number and expiration date were not reported). Additional information is not expected.
Patient reported feeling anxious and sensation of vertigo Patient seen by medical team and refused medical transport and signed AMA form Patient stated symptoms improved
This spontaneous report as received from a registered nurse refers to a anonymous multiple patients of unknown age and gender. On unspecified date COMVAX (lot #, expiration date, strength and dose were not reported) was administered to multiple anonymous patients post supported temperature excursion. No concomitant medications were reported. No adverse effects reported by any patients. Additional information has been requested.
Client began having pain in legs and back approximately 8 days after vaccination with Smallpox Dryvax vaccine
knee surgery after first dose; This spontaneous case was reported by a consumer and describes the occurrence of KNEE OPERATION (knee surgery after first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-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 KNEE OPERATION (knee surgery after first dose). At the time of the report, KNEE OPERATION (knee surgery after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  Patient took Tylenol, Prednisone, Celecoxib and aspirn.
About two days after shot had sore throat and fatigue.  Began running fever of 100 - 102 later in day and extreme fatigue set in.  Am still running fever and fatigued after normal daily activities 9 days after shot and 7 days after first onset of side effects.
Case number PHEH2015US026912, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 55-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 21 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The nurse stated that, the reason was unknown for the refrigerator to be out of temperature range. There was no any further problem since the temperature excursion problem. No further information was provided. No adverse reaction was experienced by the patient following the medication error. Follow up report received from nurse in 26 Jan 2016: Updated reporters comments.
Local reaction that was red then turned purple right in center of local reaction, tender several days; observed per provider 8/28/08 nickel size purple area - it faded to red at present.
Since my 4 VX shots I haven't had one episode of the EBV reactivating; Since my 4 VX shots I haven't had one episode of the EBV reactivating; 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 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I have chronic active EBV" (unspecified if ongoing); "Every 6/8 weeks swollen neck lymph nodes for years" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), PRE-EXISTING CONDITION IMPROVED (non-serious), outcome "unknown" and all described as "Since my 4 VX shots I haven't had one episode of the EBV reactivating".  Additional Information: Patient had chronic active EBV. Every 6/8 weeks swollen neck lymph nodes for years. Since patient's 4 VX shots patient haven't had one episode of the EBV reactivating.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
His tongue became puffy; Allergic episode after being on the elliptical bike.; Diagnosed with angioedema from a urologis; Genitals became swollen; A spontaneous report  was received from a healthcare professional concerning reporter's husband who is a male patient of unknown age, who received Moderna's COVID-19 Vaccine (mRNA-1273) experienced puffy tongue, angioedema,  genitals became swollen and allergic episode after being on the elliptical.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received his first of two planned doses of mRNA-1273 (Batch number not provided) on an unspecified date. On 05 Feb 2021, approximately 5 days prior to the onset of the symptoms, the patient received his second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 09 Feb 2021, initially patient was diagnosed with angioedema and swollen genitals from a urologist and then diagnosed with angioedema and allergic episode from a cardiologist on 23 Feb 2021. the patient was hospitalized on 15 Mar 2021 for puffy tongue.  Treatment for the event included Benadryl for angioedema from a urologist when genitals became swollen.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The events, diagnosed with angioedema and swollen glands from a urologist  were recovered on 12 Feb 2021. The outcome of the events, tongue became puffy, angioedema and allergic episode from a cardiologist, after being on the elliptical bike  were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Last night I took a Tylenol PM to help me sleep; low energy; just little joint (in the feet and arm) problems; I just feel a little different; My arm hurt more than the first shot; This is a spontaneous report received from a contactable consumer (patient). A 60-year-old male patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 09Apr2021 at 08:00 as a single dose for COVID-19 immunization. Medical history included a rotator cuff injury. The patient had never had a flu shot and had been healthy overall. Concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on 19Mar2021 for COVID-19 immunization and experienced arm hurt. On 09Apr2021, the patient experienced "I took a TYLENOL PM to help me sleep." On an unspecified date in Apr2021 after dose 2 of BNT162B2 the patient experienced arm hurt more than the first shot, low energy, just little joint (in the feet and arm) problems. He didn't feel tired. He just felt a little different. The patient was treated with diphenhydramine hydrochloride, paracetamol (TYLENOL PM) on 09Apr2021 to help him sleep. The outcomes of arm hurt more than the first shot, low energy, and just little joint problems were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021392759 same reporter/patient, different vaccine dose with different AE;US-PFIZER INC-2021407626 same reporter/drug, different patient/AE;US-PFIZER INC-2021407624 same reporter, different patient/AE
1-2 weeks post vax the pt experienced rash with itching which came and went. A doctor visit was required and she was treated with prednisone for 6 days and Atarax. The most recent information received reports the condition of the pt is ongoing.
Shot given at 1557 hours. That evening at home, patient felt flushed and nauseated without any other new symptoms. Went to bed. Awoke the next day with numerous small, round, fluid-filled bumps on the arms, legs, chest and back. Lesions were itchy and minimally erythematous. They drained clear fluid when opened. When scratched they seemed to turn more red and enlarge. Nausea persisted for 4 days. Lesions persisted for 6-7 days. Treated pruritus with OTC BENADRYL and then sought care on day #5 and was given ZYRTEC. Took one dose and next day or two the lesions had resolved. Still has some residual hyperpigmentation at the lesion sites 2 day later.
Congestion; Sore throat; Feverish 98-100.8F body temperature; This is a spontaneous case received from a contactable consumer (patient). A 21-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on 18Mar2021 (Batch/Lot number unknown) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. On 19Mar20201, the day after vaccination, the patient developed congestion, sore throat and feverish 98-100.8F body temperature. She wants to know if these symptoms are normal side effects of the vaccine or if she has an illness. The outcome of events congestion, sore throat and feverish was unknown.  No follow-up attempts possible; no request for batch number will be pursued.