chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received the booster dose Pfizer Covid Vaccine; received the booster dose Pfizer Covid Vaccine; the partner's blood pressure was 180/100 for 12 hours; This is a spontaneous report from a Pfizer sponsored Program. A contactable consumer reported for a 68-year-old female patient (reporters partner). A 68-years-old female patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on 05Mar2021 (Route of administration: Left arm, lot number: EN6206) and received second dose of BNT162B2 on 26Mar2021 (Route of administration: Left arm, lot number: ER8732) for covid-19 immunisation. On an unknown date the patient experienced received the booster dose pfizer covid vaccine. On an unknown date in 2021 the patient experienced the partners blood pressure was 180/100 for 12 hours. It was reported that the caller received the booster dose Pfizer Covid Vaccine on Monday, 27Sep2021 and is still feeling effects. When the caller received the second dose Pfizer Covid Vaccine the caller was light headed and tired for about one or two days. After the caller received the booster dose Pfizer Covid Vaccine, he has been light headed, tired, temperature reached over 100, heart rate was 120 to 130. Everything came down but the caller still feels bad now 5 days after receiving the booster dose Pfizer Covid Vaccine. The caller enquired why he was still feeling effects 5 days after receiving the booster dose Pfizer Covid Vaccine. Are the effects the caller is feeling from the booster dose Pfizer Covid Vaccine. When the callers partner received the booster dose Pfizer Covid Vaccine, the partners blood pressure went up to 200. Caller confirmed details provided by the transfer agent. The callers partner gets on the phone and clarifies the partners blood pressure was 180/100 for 12 hours. The patient states she reported her reaction after receiving second dose Pfizer Covid Vaccine online with Pfizer. The patient clarifies the blood pressure of 180/100 for 12 hours was reported on the patients initial report filed online with Pfizer. The patient underwent lab tests and procedures which included blood pressure measurement: 180/100 on an unknown date. The outcome of the event the patient experienced the partners blood pressure was 180/100 for 12 hours was resolved on 2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
disruptive sleep; no energy/couldn't get up the couch; couldn't concentrate; headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (disruptive sleep), ASTHENIA (no energy/couldn't get up the couch), DISTURBANCE IN ATTENTION (couldn't concentrate) and HEADACHE (headache) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included IgA deficiency.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced INSOMNIA (disruptive sleep), ASTHENIA (no energy/couldn't get up the couch), DISTURBANCE IN ATTENTION (couldn't concentrate) and HEADACHE (headache). At the time of the report, INSOMNIA (disruptive sleep), ASTHENIA (no energy/couldn't get up the couch), DISTURBANCE IN ATTENTION (couldn't concentrate) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported No treatment medications were reported    Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: Follow-up information received on 29-Mar-2021 contains non-significant information.
Patient reported 2 areas that were red and sore 24-48 hours after the immunization. The 1st area was at injection site and was about 1.5"x 1.5" and the 2nd area was on the bicep area of same arm near the elbow which the painful rash was about 3" x 5" in size. Patient also reported that her skin on the back of her neck and shoulder was sore to touch and hot. Patient reported a fever about 24 hours after immunization and malaise for 48 hours. Patient stated she felt like she was getting shingles. Patient stated that after 5 days she started feeling better.
Pt reports soreness in (L) arm on Fri eve which progressed to cold sweats, generalized body aches, felt like "he had the flu". No redness, swelling, cont cold packs per Dr on Mon "Flu symptoms" gone. Taking 600 mg Advil 3x daily. Pain from (L) shoulder to elbow w/movement & sleep disturbed.
A report has been received from a Health Professional concerning a 10 year old patient of unknown gender, who received Nasal FLUMIST Quadrivalent (Intranasal), 0.2. milliliters, Once/Single administration. FLUMIST Quadrivalent (Intranasal) started on 08-JAN-2016 for Influenza. Two siblings received expired FLUMIST and product quality complain was reported. FLUMIST Quadrivalent (Intranasal) was discontinued on 08-JAN-2016.  The patient recovered from the event Expired FLUMIST on 08-JAN-2016 and the outcome of the event of Product Quality issue was unknown. The reporter's description of the events(s) was as follows: None reported.  The report was considered to be non-serious.
2nd vaccine - at 20 mins of administration, I felt my  lower part of my tongue and epiglottis area  was swelling. BP (R) arm 189/103  Pulse-106 . Benadryl 25mg was given ..After 10 mins BP 132/74. My taste was altered  when  I had chicken soup  an hour after the vaccine.
Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-OCT-2017, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 lot number M007768 with expiration date on 27-JUN-2017 (dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported.
Pt started w/a bad H/A Saturday, and started w/ leg pain yesterday afternoon (8/15/16) w/ burning when legs are straight.
No additional AE/PQC identified; vaccine that underwent a temperature excursion was administered to a patient; Information has been received from a nurse referring to a 42 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On 06-AUG-2020, the patient was administered with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S015961 and expiration date 23-MAY-2021; strength, dose and route were unknown) that underwent a temperature excursion (product storage error). The vaccine was exposed to temperature excursion at above 47 degrees Fahrenheit (49.3 degrees Fahrenheit) for 43 minutes, above 47 degrees Fahrenheit (49.3 degrees Fahrenheit) for 93 minutes and above 47 degrees Fahrenheit (49.6 degrees Fahrenheit) for 30 minutes. The cumulative time was 2 hours and 52 minutes. There was no previous temperature excursion. The call was due to digital data logger. No additional adverse events were identified.
HCP to return call with actual number of recipients vaccinated post expiry.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP to return call with actual number of recipients vaccinated post expiry.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) 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 EXPIRED PRODUCT ADMINISTERED (HCP to return call with actual number of recipients vaccinated post expiry.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP to return call with actual number of recipients vaccinated post expiry.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.  The vial with Lot 038C21A, 4 vials had been used or administered, 1 open or punctured, other one was half used. Five vials remained unpunctured.  Sticker from State was 035C21A with expiration date as 30Dec2021 (extended expiration).   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: Non-Significant Follow up- email information updated.
BLOOD CLOTS; This spontaneous report received from a consumer concerned multiple patients (8 patients) Patients weight, height, and medical history were not reported. Patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, 8 patients got blood clots so they stopped using JANSSEN COVID VACCINE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210533746-COVID-19 VACCINE AD26.COV2.S-Blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Originally admitted from SNF for pyelo and fungemia. COVID + on 1/10 prior to SNF dc. Active infection that required O2, steroids, zinc, singulair and remdesivir. DC to SNF on O2.
No adverse event. Subsequently found out patient received the same Prevnar 20 dose on 5/26/23, we were not informed
light heaed; flu symptoms; couldn't sleep; left breast became solid; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light heaed), INFLUENZA (flu symptoms), INSOMNIA (couldn't sleep) and BREAST INDURATION (left breast became solid) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K2074) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced DIZZINESS (light heaed), INFLUENZA (flu symptoms), INSOMNIA (couldn't sleep) and BREAST INDURATION (left breast became solid). At the time of the report, DIZZINESS (light heaed), INFLUENZA (flu symptoms), INSOMNIA (couldn't sleep) and BREAST INDURATION (left breast became solid) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns an 86 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
erythema  greater than 100 mm; This non-serious case was reported by a physician via sales rep and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced erythema (Verbatim: erythema greater than 100 mm). The outcome of the erythema was unknown.   It was unknown if the reporter considered the erythema to be related to Shingrix.     It was unknown if the company considered the erythema to be related to Shingrix.   Additional Information: GSK receipt date: 01-AUG-2023 The physician would like information regarding Shingrix.  The reporter enquired that if a patient had experienced erythema greater than 100 millimeter, when they received their first Shingrix dose 100 mm, should they receive their second dose? Medical Information Agent decided reported the current adverse event (AE) just to stay on the safe side and due the specific description of erythema mentioned by the physician. The reporter consented to follow up.
I had my 2nd Covid shot on March 13, 2021. I waited my 15 minutes then headed home. Thank goodness my husband was driving because my eyes wouldn't stay focused on anything. They just kept jumping from one thing to another all evening. The next day I noticed I wasn't seeing like I should. It was like part of my vision was missing out of my left eye.  I decided to see an eye doctor ad they sent me to a retina specialist.
Skin Lesion; Skin erythema - Information has been received from a physician concerning a healthy, normal 47 month old male with no immunsoppression, no concomitant medications, and no significant medical history and a possible penicillin allergy who on 22 Aug 1997 was vaccinated im with one dose of varicella virus vaccine live (lot 622978/068k) (site unknown).  on 11 May 2000 the patient developed several lesions.  Additionally the patient has no known recent exposure to varicella.  The patient was seen by the physician and she reported 1 vesicular lesions on the helix of the right ear, and one possible vesicular  lesion on his right back.  The patient also had  4 or 5 other lesions which resembled mosquito bites.  The patients lesions were tiny papules with surrounding erythema.  The physician noted that she was not sure if the patient's lesions were chicken pox, and that some looked more pustular than vesicular.  A specimen was obtained for VZV analysis, however, when the specimen arrived at the lab it was totally smashed with nothing in it.  The test tube was examined to see if there was anything usable in it, however, the test tube was empty and thus discarded.  On an unspecified date the patient recovered.  No further information is expected. was seen by the physician and she reported 1 vesicular lesion on the helix of the right ear, and one possible vesicular lesion on his right back.  The patient also had 4 or 5 other lesions which resembled mosquito bites.  The patient's lesions ere tiny papules with surrounding erythema.  The physician noted that she was not sure if the patient's lesions ere chicken pox, and that sore looked more pustular than vesicular.  A specimen was obtained for VZV analysis, however, when the specimen arrived at the lab it was totally smashed with nothing in it.   The test tube was examined to see if there was anything useable in it, however, the test tube was empty and thus discarded.  On an unspecified date the patient recovered.  No further information is expected.
received both doses of vaccine and tested positive for Covid-19; received both doses of vaccine and tested positive for Covid-19; This is a spontaneous report received from a contactable male patient of an unspecified age received first dose and second of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), intramuscularly on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received both doses of vaccine and tested positive for covid-19. On an unspecified date the patient underwent lab tests and procedures which included COVID-19 test positive. The outcome of the events were unknown.  Information about the Lot/batch number has been requested.
little sore arm; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 04Apr2021 (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation; estrogens conjugated (PREMARIN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. Patient called in seeking assistance with the medication Premarin. During the call patient stated." I'm a little bit dumb. Patient later stated on the call." I just got the Pfizer vaccine too 04Apr two of them all I had was a little sore arm." The outcome of the event was unknown.  Information about lot/batch number has been requested.
a patient was given an expired dose of Twinrix today; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix adult) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 10-OCT-2023, the patient received the 1st dose of Twinrix adult. On 10-OCT-2023, an unknown time after receiving Twinrix adult, the patient experienced expired vaccine used (Verbatim: a patient was given an expired dose of Twinrix today).  The outcome of the expired vaccine used 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: 10-Oct-2023 Pharmacist declined to provide patient's demographics because of privacy concerns. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. The patient received an expired dose of Twinrix adult, which led to expired vaccine used.
pt recv vax & devel blood in stools;pt hosp;gastroenterologist dx allerg enteropathy w/dehydration;pt recovered;
pt recv vax 9JAN96 & began crying & would not nurse;pt treated w/APAP & ice;1hr later pt nursed a little & cried intermittently;this is 1 of 4 pt from this site to report adverse rxn;
itchy hives on face, muscle aches to the point that I could not get out of bed, congested
Had It, this is awful/Suspected vaccination failure; Had It, this is awful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 27-Jan-2023  Reporter's comment: This case was reported by a patient via interactive digital media. The patient had the Shingles shot. The patient stated that this was awful the patient was at the end the patient hope, the patient had it (shingles) for three weeks. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Patient reports feeling extreme arm pain, difficulty moving arm, and nausea while attending church at approximately 6:00 PM. Reported to Emergency Department where he was examined and released later that night with a sling for his arm.
Cellulitis; Injection site erythema; Pyrexia; This case was receivedon 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of CELLULITIS (Cellulitis) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant), INJECTION SITE ERYTHEMA (Injection site erythema) and PYREXIA (Pyrexia). At the time of the report, CELLULITIS (Cellulitis) and INJECTION SITE ERYTHEMA (Injection site erythema) outcome was unknown and PYREXIA (Pyrexia) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other Meds :  Symptom Text : She had a fever 12 hours after 2nd dose of moderna vaccine and resolved after 2 days. She went to urgent care due to redness at injection site. She was told her had cellulitis and given antibiotics.  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.; Sender'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.