chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. The patient stated, shingles was brutal. The patient also reported that, the vaccine had side effects, especially if you did not rest. All the same, the patient had two different vaccinations and would get a third to avoid shingles. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation were not provided.
Headache, Arthralgia, NauseaVomiting, L arm pain, fatigue
This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical History was not reported. The reporter informed that an unspecified dates since 22-MAY-2014, the patients received ROTATEQ (lot # J012518, expiration date 24-APR-2015) oral, dosage and strength were not reported. Concomitant therapy was not reported. The reporter stated that from 22-MAY-2014 until 27-MAY-2014 the ROTATEQ was improperly stored at 66 F (the total duration of exposure was 5 days). No known adverse effects were reported. Additional information has been requested.
Twinrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 26th November 2022).   On 11-APR-2023, the patient received the 2nd dose of Twinrix. On 11-APR-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix late second dose). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-JUN-2023 The reporter reported that late second dose of Twinrix was administered to a patient and an early third dose was being considered. No consent to follow up because hcp declined to store information. The reporter reported that the patient got late second dose and at the time of reporting attended the pharmacy requesting a third dose, healthcare professional called to ask medical information to make a decision.  No details on patient or vaccine were reported. The reporter did not consent to follow-up. The patient received the 2nd dose of Twinrix late than the recommended schedule, which led to lengthening of vaccination schedule.
1st time patient received flu shot.  Itching, redness face, little on top of chest, none on arms/back or body.  BP 153/79, pulse 8.  Gave Benadryl 50 mg, advised q 6 hours x2 days, then see MD.  Gave pt. Benadryl if continues.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Administered 1st dose of Pfizer COVID-19 series subcutaneous in the arm. Within 30 seconds, patient became unsteady and pale. Patient loss consciousness for 30 seconds. Blood pressure, body temperature, and heart rate all remained normal. Patient regained conciousness, was provided with water and crackers, and stated that he felt better. Mother has a history of passing out after receiving vaccines.
Bruising at injection site, pain at injection site, swelling at injection site, headache, muscle pain, fever, severe dizziness, and fainting. Also had severe joint pain.
1. Shock likely hypovolemic  - presents with chest pain, shortness of breath, presyncope, shaking chills, all symptoms started in last 24 hours, hypotensive with systolic BP in 60s, BP still in 90-100s despite 3 lt IV fluids and 10 mcg levophed, afebrile, WBC normal, hemoglobin 11.3, no recent baseline, no active bleeding noted, lactate 1.9, labs indicate elevated anion gap metabolic acidosis, also has positive urine ketones and trace acetone in serum, troponin -ve x 1, pro BNP normal, LFTs and lipase normal, testing for influenza A/B and SARS-CoV2 negative,, UA no pyuria. Has AKI, EKG NSR, no st-t changes, low voltage QRS noted, CXR negative for acute findings, CTA chest, CT abdomen/pelvis, CT head and CT cervical spine negative. Has been on lot of stress lately as she had to get COVID vaccine, has type 1 DM on insulin pump  - based on this has shock likely hypovolemic due to DKA, septic shock seems unlikely due to absence of clear infection source, adrenal insufficiency is in differential especially if shock fails to respond to therapy  - continue IV levophed, start DKA protocol with IV insulin, received dose of ceftriaxone in ER, will monitor off abx for now, low threshold to start abx if spikes fevers or hypotension persists, trend troponins, monitor H&H, please f/u blood Cx and serum cortisol results 2. DKA (diabetic ketoacidosis)    - please see problem #1, labs indicate elevated anion gap metabolic acidosis, also has positive urine ketones and trace acetone in serum, Has been on lot of stress lately as she had to get COVID vaccine, has type 1 DM on insulin pump, also elevated anion gap persists despite fluid resuscitation  - based on this has DKA, recent stress might be driving the DKA  - start DKA protocol with IV insulin, hold insulin pump while on IV insulin 3. AKI (acute kidney injury)  - serum creatinine 1.1 from baseline of 0.7-0.8, BUN 18, AKI is likely prerenal, continue IV fluids and levophed as above 4. Anemia  - hemoglobin 11.3, no recent levels available, denies active bleeding, MCV normal, will monitor H&H, consider further evaluation as appropriate 5. ANXIETY  - Has been on lot of stress lately as she had to get COVID vaccine, will start PRN ativan
At the time of vaccination, Lot # 040A21A at 10 minutes after the vaccine was given to me, my the glands in my throat started to swell. I went back to the pharmacy and they gave me an epi pen injection and then called 911 to get me to the emergency room. I had to take Benadryl, steroids and Pepcid AC through an IV.  They also prescribed those three medications and an epi pen to my pharmacy for an additional 4 days.  It is day two and there is a slight improvement, but the swelling is still there.  I had no issue with the first shot, Lot #013M20A.
Got vaccination and still get hot spots; This case was reported by a consumer via interactive digital media and described the occurrence of sensation of warmth in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got in his/her forties).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sensation of warmth. On an unknown date, the outcome of the sensation of warmth was unknown.   It was unknown if the reporter considered the sensation of warmth to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got shingles in his/her fortied and got shingles vaccination and still got hot spots, but no rash. The follow up would not be possible as no contact details were available
I was experiencing a lot vaginal itchiness. I got tested for a yeast infection.  Estimated date for delivery is July 17th.
Large amount of blood coming from resident wound. Resident stated "I was trying to use my urinal and it felt like I was all wet under my arm." Copious amounts of bloody drainage noted to axillary hematoma/wound, with large golf ball size clots, pressure applied to wound.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 17-MAY-2018, the patient was vaccinated with an expired dose of Oka/MerckVARIVAX injection (lot # M009764, expiration date 23-FEB-2018) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent (manufacturer unknown). The reported believed the suspect vaccine was administered intramuscularly instead of subcutaneously. No adverse effects were reported.
This is a spontaneous report from a contactable physician via Pfizer sales representative. A 66-year-old female patient received PREVNAR 13, on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported. On an unknown date after vaccination (a short time later) the patient experienced a large sore on her arm and had left a dent in the arm. The outcome of the event was unknown. Information on the batch number has been requested.
I had severe swelling of lymph nodes under the arm across my chest; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 16:00 (Lot number: EW0186) at the age of 50 years as dose 1, single and administered in arm left, administration date 10Jun2021 (Lot number: EW0180) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known Allergies - penicillin" (unspecified if ongoing); "Known Allergies - contrast dye" (unspecified if ongoing). There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "I had severe swelling of lymph nodes under the arm across my chest". Therapeutic measures were taken as a result of lymphadenopathy. Additional information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Reported event: I had severe swelling of lymph nodes under the arm across my chest and was placed on two doses of steroids to help bring down the baseball size swelling. Device date was reported as 29Sep2021.  No follow-up attempts are possible. No further information is expected.
Patient was given the second dose of Pfizer brand Covid-19 vaccine by our immunizing tech. and said patient was ok until she stood up to leave the immunization room and that is when she immediately fainted and slumped  back into the chair.  Within a few seconds she regained consciousness.  Mom said she had not eaten anything before coming and has fainted before when having blood drawn. (patient does have a fear of needles) We had the patient sit the immunization room for around 20 minutes. We got her some juice and a wet cloth upon moms request as she was sweating and shaky feeling. After sitting for a while she said she was feeling better and mom declined further care and we advised she follow up with her PCP
Several hours after patient received vaccination, he could not lift his arm. This was followed by intense nausea that kept him up all night long.
2nd dose administered to a 16 year old; 1st dose administered to a 16 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to a 16 year old) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2nd dose administered to a 16 year old) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to a 16 year old). On 10-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2nd dose administered to a 16 year old). On 12-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to a 16 year old) had resolved. On 10-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2nd dose administered to a 16 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was provided.
This spontaneous report as received from a Medical Assistant (C.M.A.) (also reported as nurse) refers to a unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a doses of VAQTA dose number, lot# and expiration date was not reported, which underwent a supported temperature excursion. No adverse effects reported. Follow-up information has been received. On 04-FEB-2015 several telephone attempts were placed to the certified medical assistant however she was unavailable at the time of calls. This one of several reports from the same reporter. Additional information has been requested.
PATIENT LOSS COUNCIUSNESS FOR ABOT 20 SECOND AFTER VACCINATION WAS GIVEN.  IT WAS REALLY HOT OUTSIDE AND PATIENT REPORTED NOT DRINKING WATER SINCE MORNING. PATIENT ALSO HAVE NEEDLE FOBIA. 911 WAS CALLED, BY THE TIME HELP CAME PATIENT WAS DOING FINE. WE GAVE HIM PEDIALITE WHICH HELPD HIM WITH SWEATING. FIRST RESPONDER CLEAR HIM AFTER BP AND EKG CHECK. PATIENT DENIED GOING TO THE HOSPITAL FOR ANY FURTHER HELP.
red spot the size of a quarter at the injection site; hardness at the injection site; a minor lump at the injection site; injection site itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (red spot the size of a quarter at the injection site), VACCINATION SITE DISCOMFORT (hardness at the injection site), VACCINATION SITE MASS (a minor lump at the injection site) and INJECTION SITE PRURITUS (injection site itching) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A01A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE BRUISING (red spot the size of a quarter at the injection site), VACCINATION SITE DISCOMFORT (hardness at the injection site), VACCINATION SITE MASS (a minor lump at the injection site) and INJECTION SITE PRURITUS (injection site itching). At the time of the report, VACCINATION SITE BRUISING (red spot the size of a quarter at the injection site), VACCINATION SITE DISCOMFORT (hardness at the injection site), VACCINATION SITE MASS (a minor lump at the injection site) and INJECTION SITE PRURITUS (injection site itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: NNI
Approx 30 min after administration- chest pressure, slight SOB, metallic taste in mouth. 4 hours after vaccination headache, nasal congestion, muscle pain, joint pain, redness to left arm (shoulder to elbow), fever up to 103, chills, shaking with the chills, nausea, sore arm
Fever; Extreme body aches; headache; lethargy; earache; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received second dose of BNT162B2 (BNT162B2; Lot number and expiry date not available), via an unspecified route of administration, in left arm on 08Apr2021 at 18:00 (at the age of 31-year-old) as a single dose for COVID-19 immunization. Medical history included sickle cell trait. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (Lot number and expiry date not reported), via an unspecified route of administration, in left arm on 18Mar2021 at 18:00 as a single dose for COVID-19 immunization. The patient had no known allergies. The patient was not pregnant. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced fever, extreme body aches, headache, lethargy and earache on 09Apr2021. The events were reported as non-serious. The patient underwent lab tests and procedures which included nasal swab test: unknown results. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number can be obtained.
At approximately 3 AM on 11/02/05, patient deloped a rash on her right arm that "felt like bug bites".  Rash persisted on right arm and was itchy.  On 11/04/05, patient started taking Benadryl tablets and itching and rash resolved within 2 days.
Diarrhea; severe lower back pain; This is a spontaneous report from a contactable consumer.  A 54-year-old male patient received patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm at the age of 54-years, on 05 Mar 2021 at 01:00 pm at a single dose for COVID-19 immunisation. The patient's medical included Heart disease and Hodgkins disease from an unspecified date. He was allergic to pineapple. Patient did not test for COVID post vaccination and did not have COVID prior vaccination. On 06Mar2021, patient experienced Diarrhea, severe lower back pain.  The patient was not treated for the events. The outcome of the events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Started with gross hematuria 2 days after the vaccination. This persisted for 4 days.
At 33 5/7 weeks, less than 24 hours after receiving the Janssen Covid 19 Vaccine, patient experienced a plancental abruption that resulted in an emergency cesarean delivery of a premature infant, who has had to be in the NICU since delivery.
patient experienced syncope shortly after receiving vaccine, was laid on floor (did not fall) and was sweating profusely, blood pressure was monitored, patient was feeling better after about five minutes. Patient did state that they had not eaten anything yet that day.
Pt experienced a patch of raised, blotchy, red welts, extreme soreness and extreme tenderness to the touch on the right deltoid region of administration. This started the evening of the shot and continued until at least 2 days post-administration when patient reported it to me. Pt also experienced severe side effects similar to this but worse after 1st dose was given.
tested positive greater than 14 post 2nd dose Narrative: tested positive greater than 14 days post second dose
32 y.o. female reported fevers and fatigue which started the day following receiving Johnson & Johnson COVID vaccine on 4/10/21.  Fevers (100-103) were minimally responsive to antipyretics and lasted for 3 weeks.
Right upper arm was swollen, red and hot. Girth of right upper arm was twice the size of the left upper arm. No tenderness on 7/20/01. Rechecked on 7/23/01 and all of the above symptoms were resolved.
Patient stated pain in the arm of the injection site that was relieved with Ibuprofen day after vaccine administered. Patient then experienced swelling of the lips on 12-11-18 that was relieved with BENADRYL.
Episodes of vertigo throughout the day Fatigue comes and goes  Both started about 2 weeks after the shot
at the time of revoming the needle from patient,the needle and syring separated. as a result some of 0.5 ml dose did not go in his arm. As a result,I gave 0.25 ml additional dose to complete the vaccination. During 15 minute watch time nothing is happened.  I used HypodermicNeedle-pro Syring and needle  with needle protection Device  3ml; 23 gx1in
INCORRECT PRODUCT STORAGE; RECEIVED THE JANSSEN COVID-19 VACCINE AFTER THE PRODUCT WAS EXPOSED TO MULTIPLES TEMPERATURE OF EXCURSION; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 22-FEB-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported.  On 22-FEB-2022, the patient experienced received the janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received the Janssen covid-19 vaccine after the product was exposed to multiples temperature of excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220649045, 20220649137, 20220649370, 20220649417, 20220649421, 20220649626, 20220649704, 20220650014, 20220649488, 20220649803, 20220649884, 20220649915, 20220650111 and 20220650185.
2 days old patient was administered; This spontaneous report as received from a physician refers to a 2-day-old neonate patient.     The patient's medical history, current condition, drug reactions/allergies and concomitant medications were not reported On 23-APR-2020, an unspecified 2 days old patient was administered the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot#S017631, expiry date: 08-DEC-2020, strength, dosage information were not reported) for prophylaxis (product administered to patient of inappropriate age). The outcome of product administered to patient of inappropriate age was unknown. No additional AE information. No further information provided. No product quality complaint (PQC).
Case number PHEH2013US020264, is an initial spontaneous report received from a physician on 25 Sep 2013. This case refers to a 62 years old female patient. The patient had hypoglycaemia. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 25 Sep 2013. Reported stated that, during vaccination, the patient slumped over. Only half dose of prefilled syringe was administered due to the fall. The seriousness and outcome of the event was not reported. The physician reported that it was not a reaction to the medicine but that she had hypoglycemia. No more information was available.