chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician via a company representative referring to a 13 year old female patient. Information about patient's current conditions and medical history was not reported. On 15-APR-2015 the patient was vaccinated with her first dose of GARDASIL (single dose 0.5ml suspension/1 injection, intramuscularly for prevention of HPV). Concomitant medications were not provided. On 15-APR-2015 the patient experienced an acute "severe, temporal headache, right at the temporal node" immediately after receiving her first dose [of a suggested three dose series] of GARDASIL. It was reported that the event occurred in the physician's office. Ibuprofen was given for the event. It was reported that therapy with GARDASIL was continued. Outcome of the event was not reported. The causality was not provided. Additional information has been requested.
Pt recv vax on 9/25/95; on 5/5/99 pt exp varicella rash
Swelling in the arm. Redness - ball like knot. Hot to touch. Painful - 4-5 days approx. PO BENADRYL wasn't enough went to urgent care.
Developed redness at injection site. Rash started on left arm and spread to both arms, both legs, chest and face.  Leg weakness, muscle aches. Treated with Zyrtec, Ibprofen and Benadryl. As of today 12/25/21 the rash is still present.
This is a spontaneous report from a contactable medical assistant who called on behalf of a physician. A 70-year-old female patient received PREVNAR 13 (lot H83180, expiration date 01Sep2015), on 21Aug2014, as a single dose to the upper deltoid of left arm for prevention of pneumococcal pneumonia, administered for the first time by a nurse. No other vaccine was given at that time. Medical history included hypertension and high cholesterol since 2007. Concomitant medication included lisinopril/hydrochlorothiazide/10/0.5 mg half a tablet per day for hypertension and pravastatin 20 mg three times daily. The patient experienced myalgia, arthralgia and diarrhea later in the day on 12Aug2014. The patient did not require any visits to the hospital or emergency. No investigations were done. The patient recovered from myalgia, arthralgia and diarrhea on unspecified dates. Per the reporter the events were related to the PREVNAR 13. Follow-up (12Mar2015): Follow-up attempts completed. No further information expected.
Symptoms of generalized purities ,and rash on skin and taken OTC Cetrizine. 11:20 Escalating symptoms of abdominal pain w/vomiting ,tachycardia ,mouth dryness and  >BP was given Epi. 0.3 injection.  11:27 am Benadryl 50mg orally.  11:30 Transported to local ER via paramedic.  "
Fixed papular pruritic rash started on 12/18/12, in-between thighs/legs, now all over. Hydrocortisone 2.5% 30Gm tube BID was prescribed; helps and relieves the itch.
He got hives all over his body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: URTICARIA (non-serious), outcome "unknown", described as "He got hives all over his body".  Additional information: On 08Nov2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine at primary series (2 doses) and a booster for COVID-19 immunization. It was reported the patient had a reaction, and the reaction was that he got hives all over his body.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse events reported.  Patient was given the second dose for the hepatitis A vaccine earlier than indicated (rather than 6-12 months after the first dose which was given on 7/4/2021).
Disruption in menstrual cycle.; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included cetirizine hydrochloride (ZYRTEC), unspecified birth control (MANUFACTURE UNKNOWN), ibuprofen (ADVIL), probiotics (MANUFACTURER UNKNOWN) and fish oil (OMEGA 3) taken for unspecified indications, from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 31Mar2021 at 12:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. On 01May2021 at 14:00 the patient experienced disruption in menstrual cycle. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event disruption in menstrual cycle was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Mom telephoned with in 24 hours after receiving PCV13 developed 3 hives near injection site, resolved on their own - no BENADRYL given.
Hives-like rash beginning several days after injection, lasting now ten days.  All over the body except face and feet
A report has been received from a Health Professional concerning an 8 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 14-Jan-2014. The patient was administered expired FLUMIST to two patients which started on 14-Jan-2014. FLUMIST QUADRIVALENT (Intranasal) was discontinued on 14-Jan-2014. The outcome of the event of administered expired FLUMIST to two patients is unknown. The report was considered to be non-serious. Corrected report 18-Mar-2014: Form completed date was updated. Summary of follow-up information received by AstraZeneca/MedImmune on 24-Mar-2014 from a Health Professional: Lot no and Expiry date was added. Form completed date was updated.
Brought to observation area on wheel chair @ 12:07 PM, she was clammy , dizzy, pale. Layed on stretcher. @ 12:08 PM, PR 77, RR 16, BP 91/55, O2% 100, apple juice x1.@ 12:18 pm , PR 65, RR 18, BP 102/70, O2% 100. @ 12:32pm, PR 62, RR 18, BP 107/71, O2% 99 , apple juice x1. @ 12:44 PM, PR 71, RR 16, BP( Sitting) 106/70, O2% 99. Pt stated she is feeling better and she can walk out. Walked out to Exit.
pt recvd vax; 11aug95 devel a fever & severe 8 cm x2 cm indurated area at inject site;
Swelling and redness start 10 x 13cm over left thigh starting 10-12 hours after vaccine. Came to office. Treated for presumed infection with cladenysin.
Injection sight pain Chills Muscle Aches - day 2 Headache - Day 2 and 3 Fatigue - Day 1,2,3+ Coughing Lung pain Shortness of Breath Chest Pain
pt. was originally given a pediatric dosage of hepatitis b. Clinic was contacted, who recommended re-vaccination with age appropriate dosage. no harm to pt.
Thirty-six hours following injection noted redness, swelling and warmth progressing over next 12 hours. No fever, systemic signs of illness.
Myalgia, Fever, Low Grade Temp of 100 Narrative:  Employee was given 2nd vaccine at day 15 not day 28
I was puking, lethargic, headache, body aches from Dec. 30- Jan. 2. On Jan 2, 2021 I went to the ER. I was given sodium chloride, nausea med and an allergy med.
Low grade fever lasting 24 hours starting day after vaccine, pain and swelling at injection site, pain in arm for 2-3 days, tired, headache and swelling of lymph nodes in arm of injection starting on day 7 after vaccine.
No additional AE reported.; temp excursion 47.9; This spontaneous report was received from a medical assistant referring to a 4-month-old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not provided.  On 01-DEC-2022, doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion of 47.9 Celsius degrees (C) for 47 minutes which occur as a result of a reading from a digital data logger (Product storage error).  On 28-DEC-2022, the patient was vaccinated with aforementioned doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (lot #W006596 with an expiration date on 11-OCT-2024), administered intramuscularly in left thigh for prophylaxis (strength and dose were not provided); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot #1892784 with an expiration date on 03-DEC-2023), administered orally for prophylaxis (strength and dose were not provided). These were the second doses of both vaccines administered (number of previous doses was also reported as one, no details provided).  No adverse events were reported.
Arm was a little weird and hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was a little weird and hurting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm was a little weird and hurting). At the time of the report, VACCINATION SITE PAIN (Arm was a little weird and hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product details were provided by the reporter. No Treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up  received- Email address of the reporter and Patient gender and Patient initials has been added.
Woke up dizzy and occurred about 4-5 times Saturday and dizziness 2-3 times Sunday.  None today. Pt. checked his BP and blood sugar and both were normal per patient.
sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore shoulder) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (sore shoulder). At the time of the report, ARTHRALGIA (sore shoulder) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Intravenous fluids (I.V) were given as treatment.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Follow-up received contains additional treatment was added.
This spontaneous report was received from a registered nurse regarding a 16-months old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with improperly stored doses of M-M-R II (lot # N013868, expiration date 04-MAY-2019 (strength, dose, frequency and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. There was no adverse effect reported. The administered doses of vaccine experienced a temperature excursion of 9 to 25 (8.6) degrees Celsius for 16 minutes. Data logger was involved. There were no previous excursions reported. This report was not associated with a product quality complaint. This was one of several reports received from the same reporter.
not feeling well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 41-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for covid-19 immunisation. The following information was reported: MALAISE (non-serious), 1 day after the suspect product(s) administration, outcome "unknown", described as "not feeling well".  Follow-up attempts are not needed. No further information is expected.
This spontaneous report was received from a physician via a company representative referring to a 14 year old male patient (also reported as "around 14 years ago"). The patient's medical history, concurrent conditions and drug reactions or allergies were not reported. In approximately 2016, the patient was vaccinated with GARDASIL 9 dose number: 1, intramuscular (lot number, expiration date, concentration, dose and frequency were not reported). Concomitant therapies were not reported. Additionally it was also reported that around 2 weeks after taking the first dose of GARDASIL 9, the patient experienced periods of dizziness that lasted between 4 and 6 weeks. No laboratories or studies were performed and no product quality complaint was requested. At the time of the report, the outcome of dizziness was recovered. The causality between dizziness and therapy with GARDASIL 9 was not reported. Additional information has been requested.
Erythema, edema with pain at sign of vaccine admin. Keflex susp 300 mg bid x 10 d. Benadryl PRN
suboptimal dose given (think it was between 0.2-0.3 mL); the needle popped off during vaccine administration; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (suboptimal dose given (think it was between 0.2-0.3 mL)) and NEEDLE ISSUE (the needle popped off during vaccine administration) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (suboptimal dose given (think it was between 0.2-0.3 mL)) and NEEDLE ISSUE (the needle popped off during vaccine administration). On 16-Apr-2021, INCORRECT DOSE ADMINISTERED (suboptimal dose given (think it was between 0.2-0.3 mL)) and NEEDLE ISSUE (the needle popped off during vaccine administration) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported. Action taken with mRNA-123 was not applicable.
VARICELLA vaccine (along with TDAP & HEP A, and MENATRA) given 3/31/09 (1388 IM VERIVAX lot) onset (acute) Bell Palsy VII on 4/4/09.
BODY ACHES, RUNNY NOSE, FLU LIKE SYMPTOMS Narrative:
This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient administered the Moderna Bivalent as the 1st primary dose) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jan-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (patient administered the Moderna Bivalent as the 1st primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient administered the Moderna Bivalent as the 1st primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient administered the Moderna Bivalent as the 1st primary dose).    Concomitant medications details were not reported by the reporter. Patient did not have any previous COVID-19 vaccines besides the bivalent.  Treatment details was not reported by the reporter.
Achiness, tenderness, and burning sensation in arm where shot was given starting on 12/3/18 through entire month. Shot was given approx. 4 inches below shoulder. No redness. No fever. Last few days, symptoms have lessened and improved.
"a lump on her upper arm at the injection site with a rash that is now travelling down her arm".; the patient experienced an "injection site reaction"; "a lump on her upper arm at the injection site with a rash that is now travelling down her arm"; "a lump on her upper arm at the injection site with a rash that is now travelling down her arm"; This spontaneous report was received from a pharmacist, referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 03-AUG-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (dosage, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number and expiration date were not reported), as prophylaxis. Following the administration of the vaccine the patient experienced an "injection site reaction", she called the pharmacist, and the pharmacist described the reaction as "a lump on her upper arm at the injection site, with a rash that was travelling down her arm" (injection site mass, injection site rash and rash).   The outcome of the events injection site reaction, injection site mass, injection site rash and rash were reported as not recovered. The causal relationship between the aforementioned events and therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), was not provided.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 22Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures taken as a result of the event included paxlovid from 16May2022 to 20May2022.   Product Quality provided investigational results on 01Jun2022 for BNT162b2: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 7142695 (see File attachment in this investigation record) The complaint for "PFIZER- BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FM9992. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
I developed welts, very itchy and blotchy, there was one on my left arm, left side of neck and one big one below my neck or upper back; I developed welts, very itchy and blotchy, there was one on my left arm, left side of neck and one big one below my neck or upper back; I developed welts, very itchy and blotchy, there was one on my left arm, left side of neck and one big one below my neck or upper back; Itchy skin rash, on my right side; This is a spontaneous report from a contactable consumer (patient). This 63-year-old female patient reported that the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: unknown) via an unspecified route in Left arm as a single dose on 13Apr2021, for covid-19 immunization (age at vaccination: 63). The patient medical history and concomitant medications was not reported. On 21Apr2021, the patient experienced itchy skin rash, on her right side, she had the shot in the left arm. It subsided, then 2 to 3 days later, this past Sunday 25Apr2021 the patient developed welts, very itchy and blotchy, there was one on her left arm, left side of neck and one big one below her neck or upper back. Occurred a week and day after. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
extreme tiredness; soreness in the injection spot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Lot number: EP7534, Expiration Date: 31Jul2021) as dose 1, single and administration date 06Apr2021 (Lot number: ER8734, Expiration Date: 31Jul2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol was middle to middle high" (unspecified if ongoing). There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "extreme tiredness"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "soreness in the injection spot". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue, vaccination site pain.  Follow-Up (01Nov2021): Follow-up attempts are completed. No further information is expected.
I got COVID-19. I had a mild fever for a couple days, severe headaches for 3 days, and scratchy throat. I did take PAXLOVID for 5 days.
Patient did not have any adverse reaction to the injection, just wanted to document this just in case if there were to be an adverse reaction