chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # reported as N018273, expiration date 17-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47.5 degrees Fahrenheit for 1 hour 30 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint has been filled. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007677: US-009507513-1709USA007678: US-009507513-1709USA007679.
Had previous series 2001 of rabies vaccine. Woke up 4/3/15 with joint aches, sorenss and fatigue. Went to work ok. Work up 4/4/15 with hives on back of scalp, itchy-continued to spread 4/5/15-approx 3 am-covered in hives, felt funny in throat went to ER. D/C worse few hours later went back to ER. Saw allergist now on prednisone spread out instead of lump dose.
There has been a tumor found on my spine that was not there before and if directly related with some chest pain issues I was dealing (2nd and third right intercostal space and t6-t7 tumor on my spinal cord.
Itchiness at vaccine site 1 wk after shot; mild red rash 2" in diameter at vaccine site
Received vaccine on Thur 2/25/21  when woke up Friday AM   lips felt swollen upper  lower  but not visibly noticeable.  Saturday 2/27/21 when woke up noticed scattered red macular/papular rash on bilateral arms, chest, stomach and back -no itching rash even developed where a Freestyle Glucose patch had been days before and removed--rash followed in perfect circle of the patch and also around the outline of the bandaid from the shot but had also been removed and was not present when the rash started  started taking Benadryl 25 mg q 4h during day and 50 mg at HS  as of 3/4/21 rash fading some but still visible and beginning to itch  Pictures available if needed
Pt complained of feeling flushed and tightness in her chest.  Pt face was visibly red and she began to have blotches down her back.  BP 170/84 at 1:30.  Benadryl 50mg given IM at 1:40pm.  2 L of O2 via nasal cannula at 1:42pm. On call physician assessed pt at 1:42 at which time pt started complaining of nausea.  BP 132/76 @ 1:45pm.
Pt called 7 days within  flu shot voiced that she had a rash all over her body.
Patients daughter said 3 days after vaccination patient had swelling and eruptions on his arm that were blistered and oozing. He went to ER and was treated for bacterial infection but it did not work. He had a skin biopsy done and no results back yet . Pharmacist at hospital said for us to report.
Tuesday nothing, Wednesday night itching, Thursday 80mm across, 60mm height red, warm circle appeared. Pt said it is itchy. Hard lump at injection site, swelling.
Throat tightness, metal taste in mouth. Patients blood pressure and pulse ox remained normal throughout and there were no signs of oral or facial edema and no signs of accesory breathing.  Given epinephrine and benadryl on site
Pt was given GARDISIL, 9, MENVEO, and PNEUMOVAX 23 on 10-18-18. Mother state she didn't notice the adverse reaction until the next following day. Pt end up with hive. Mother took pt to emergency room - where they end up giving pt some antibiotics.
dizziness, lightheadedness, and feelings of palpitations although no elevated heart rate. Began within minutes of receiving the vaccine and persisted about ah hour. Slight dizziness and lightheadedness persisted for 4-6 hours.  Never had symptoms like this before under any circumstance.
INGESTION, RHINORRHEA, AND COUGH, GENERALIZED WEAKNESS AND FATIGUE
Hives (red, itchy rash) at place of injection. Size was approximately 4 inches in diameter. Rash started 6 days after vaccination and has lasted 6 days so far. Use of diphenhydramine every 6 hours helped ease the itch and redness.
made her four days late for her monthly menstrual cycle; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reporting for a 14-year-old female patient (reporter's daughter) that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0186, Expiry Date, NDC number, UPC number: Unknown), via an intramuscular, administered in left shoulder (Arm Left) on 21May2021 at 12:30PM (vaccinated at the age of 14 years) as DOSE 1, SINGLE for covid-19 immunization. Medical history included asthmatic. Concomitant medication included salbutamol sulfate (ALBUTEROL SULFATE) taken for asthma (she was currently not taking any medications. She had an inhaler. She would use it as needed. She had not used it). The patient did not receive any other vaccine 4 weeks prior to COVID shot. no investigation assessment done. For the first dose it made her four days late for her monthly menstrual cycle on an unspecified date in 2021. No treatment received for event. The outcome of event was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected
Polymorphic light eruption; This is a spontaneous report from a contactable consumer. A 37-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW01j8) via an unspecified route of administration right arm on 21Apr2021 at 11:00 (at the age of 37-years-old) single dose for COVID-19 immunization. The patient's medical history included muscle cramp. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not been tested for COVID-19 nor before neither since the vaccination. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0150) as single dose, administered in right arm on Mar2021 at 11.00 (at the age of 37-years-old). No reaction on previous exposure to drug. The patient's concomitant medication included ibuprofen (ADVIL 12 HOUR) taken for muscle spasms received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. On 01May2021, the patient experienced polymorphic light eruption. Its been diagnosed by patient dermatologist and patient had been managing it with prescription corticosteroids for about two months now. Patient never had this before. Patient did not required prolonged hospitalization. Patient received treatment. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
3RD DOSE MODERNA COVID VACCINE GIVEN 10/22/21, LOT #012F21A 4TH DOSE MODERNA COVID VACCINE GIVEN 4/4/22, LOT #002M21A pt had a positive COVID test 8/14/22 after c/o headache, sore throat; was prescribed Paxlovid; 8/15/22 pt admitted to local Medical Center with blurry vision, generalized weakness, lightheadedness; became bradycardia and hypotension; concern for CCB/BB toxicity; given medications; ICD/pacer rate increased to 70 bpm; soon became hypotensive again with hypoxia; required intubation; 8/16/22 transferred to alternate Medical Center in cardiogenic shock; pt's condition worsened and she was transferred to comfort care; she passed away in the hospital
Had cough and fever and sore throat starting night of March 19.  Tested negative for Covid Mach 20 when fever and other symptoms  appeared but tested positive March 22.. Began Paxlovid March 23,2023 following Virtual appointment March 22, 2023 with primary physician, DO. Did not take Atorvastin, per Dr. for 10 days after initiating Paxlovid for 5 days.
This spontaneous report was received from a certified medical assistant referring to a 19 year old non pregnant female patient. None pertinent medical history, drug reactions or allergies were reported. On 19-JUL-2016, the patient was vaccinated with GARDASIL 9 intramuscularly (site of administration, lot #, expiry date and dose were not reported). Patient's concomitant therapies were reported as none. On 19-JUL-2016, after receiving GARDASIL 9 the patient passed out and hit her head on the floor. The patient was unable to recall the event of passing out. She woke up confused and not oriented. The patient was treated (unspecified treatment) in the doctor's office and then transferred to an unspecified emergency room. No lab diagnostic studies were performed. The reporter was unsure if patient was admitted to the hospital and none lab diagnostics studies were performed. A reporting time the outcome regarding of the events was recovering. Additional information has been requested.
Pt given 3rd Dose of monovalent Moderna Vaccine in Error. Pt was due for Bivalent dose. Per pt mother, pt had no side effects. Patient was scheduled for Bivalent Moderna Dose in 2 months.
Right arm pain at injection site and temp 100.3. No redness, no edema.
COVID-19 Breakthrough case Feb 24 diagnosis, fever, headache, fatigue, diarrhea, difficulty swallowing, vomiting; This lasted for about two weeks. I took Prilosec and Ibuprofen.
pt mom reported 3-4hr p/vax pt broke out w/small, pinpoint, red rash;no fever;
flu-like symptoms; body aches and pains; fatigue; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2019, the patient received Shingrix (intramuscular). On 1st November 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain and fatigue. On an unknown date, the outcome of the influenza-like symptoms, general body pain and fatigue were resolved with sequelae.   It was unknown if the reporter considered the influenza-like symptoms, general body pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient experienced influenza-like symptoms, general body pain and fatigue. The reporter consented to follow up.
Headache & NauseaVomiting Narrative: missed work following first dose due to symptoms
Heavy menstrual bleeding in middle of cycle, 5 days before menstruation supposed to occur. Trying to conceive so unknown if pregnant.
Searing pain in left upper arm that radiated to my neck and base of skull, throbbing headache then later nausea and vomitting.  Took Tylenol and Phenergan and laid down on a heating pad for neck and arm.
We have Moderna that was left out for more than 12 hrs & used.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have Moderna that was left out for more than 12 hrs & used.) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have Moderna that was left out for more than 12 hrs & used) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have Moderna that was left out for more than 12 hrs & used.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 EXPIRED PRODUCT ADMINISTERED (We have Moderna that was left out for more than 12 hrs &amp; used.).    No concomitant medications were reported. No treatment medications were reported.
covid test result: Positive; covid test result: Positive; dose Number: 3; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An adult female patient received bnt162b2 (BNT162B2), administration date 19Nov2021 (Lot number: FF2589) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "dose Number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "unknown" and all described as "covid test result: Positive". The event "covid test result: positive" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive. Therapeutic measures were taken as a result of covid-19. 09Jan2022 cough and really bad body aches and asthma dx seen by PCP 10Jan2022 and given 20 mg PDN daily as well as Albuterol known asthma. Prior to vaccination, unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID- 19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events Immunisation, Drug ineffective, Covid-19 and suspect drug BNT162B2 cannot be excluded.
A non-serious spontaneous report of gave expired FLUMIST was received from a nurse concerning a 14-year-old male. On 03-Feb-2010, the patient received FLUMIST that expired on 02-Feb-2010. There were no subsequent adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 11-May-2010 and incorporated into the case: there were no associated adverse events.
I slept well that night and woke up felt my throat because I felt like I was choking, and it felt like I was being stabbed and then I developed a cough. I got rapid test through the mail, and it was positive and then did a PCR at my job. The very first day I had standard symptoms that Friday I had fatigue cough and the I developed a tempt that went up to 101.0 The cough was the worst I had difficulty sleeping and the fever finally stopped 24 of April. I did take TYLENOL for the temperature. Per the policy I took another test on the 25 which was still positive, and I still had the dry cough. On the 27 I had whizzing along with the cough. I had albuterol inhaler, so I used it about 3 times a day because it was worst at night, By the weekend of May 2nd I went to my family doctor. I told her that I was having chest tightness and dizziness as well as shortness of breath. At the office temperature was 99.8 oxy 96% she orders a CBC and CMP in office and a D Dash Dimer. On the same day blood work came back D Dimer was double what it should be 1.12. The CMP was normal, and the CTC was normal as well. I was sent to the hospital on 05/02/2022 at about 4pm. I was given a CT with contrast (CTA) they told me I didn't have a Polyamory Embolism. They did find a fatty mass. Before getting the results I was put on azithromycin and prednisone for a total of five days. I saw her on the May 5th and everything did resolve and then we set up cardiac visits for the mass that was found. I was cleared to go back to work on May 9th.
I had a fever last night; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 21Dec2020 at a single dose for Covid-19 immunization. The patient's medical history was and concomitant medications were not reported. The patient had the Pfizer vaccine yesterday (on 21Dec2020) and had a fever at night. The patient asked if patient has to quarantine because of that. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.
On 29/Jan/2021 At 9:10 I received the 2cnd vaccine Moderna Lot No. 01162019. At 5 PM on January 29, 2021 I started to get cold chills and a fever. Of 99.3. Followed by cold chills, headache which was moderate body aches which was moderate and stomach pains which was moderate. I did not take anything for the fever or the pain. I drank a total of 368 ounces of water on January 29, 2021.At 2 AM on January 30 ,2021 my fever was 101.1 then again at 6:45 on January 30 ,2021 my fever  was 102.8. I had severe  Bodyaches, moderate joint pain severe headache cold chills,. At 8 o?clock am,  I took 250 mg tablets of acetaminophen . The fever subsided as well as the cold chills and joint pain around 9:30 AM on January 30, 2021. AE?s start date is January 29, 2021  End dates - ongoing
Patient was given Fluarix vaccine; afterward (within a few minutes), patient stood up and passed out; patient fell and hit his head on the wall in the immunization room; patient was experiencing headaches and pain; EMS services was called and patient was transported to Medical Center; Spoke to father today (10/22/20) and patient was discharged home with no adverse effects except some headache
dizzy; tired; sore throat; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 13Mar2021 (Lot number: EN6202) at the age of 57 years as unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 18Mar2021, outcome "unknown", described as "dizzy"; FATIGUE (non-serious) with onset 18Mar2021, outcome "unknown", described as "tired"; OROPHARYNGEAL PAIN (non-serious) with onset 18Mar2021, outcome "unknown", described as "sore throat". Therapeutic measures were taken as a result of oropharyngeal pain which included ibuprofen. Additional information: Patient got the vaccine Saturday the 13th and she started feeling dizzy, tired, and sore throat but not until Wednesday.  No follow-up attempts are possible. No further information is expected.
No adverse event; Received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent 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 ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose).    No concomitant medications were provided.  Reporter saw that the dosage was changed to 0.5 ml. For the past month, reporter had been giving 0.25 ml. 19 patients received the half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022 and 06-Oct-2022.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662961, US-MODERNATX, INC.-MOD-2022-662973, US-MODERNATX, INC.-MOD-2022-662974, US-MODERNATX, INC.-MOD-2022-663147 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662973:Same reporter US-MODERNATX, INC.-MOD-2022-662961:Same reporter US-MODERNATX, INC.-MOD-2022-663147:Same reporter US-MODERNATX, INC.-MOD-2022-662974:Same reporter
Administered vaccine, patient had syncopic episode 2 minutes after. Patient was given orange juice and observed upon awakening. Vitals were checked, patient allowed to leave 30 min later.
severe rashes; burning; stinging; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, 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: RASH (non-serious), outcome "unknown", described as "severe rashes"; BURNING SENSATION (non-serious), outcome "unknown", described as "burning"; PAIN (non-serious), outcome "unknown", described as "stinging". The events "severe rashes", "burning" and "stinging" required physician office visit.  Additional information: After patient took the Pfizer Covid shot, she had severe rashes. No dermatologist has been able to find a way to relieve the burning and stinging. And asking if they had found a product that can help her.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
AREA OF INJECTION IS RED AND HOT TO TOUCH. PT STATES IT IS VERY ITCHY.
Injection site reaction- 1/2 dollar sized red, warm slightly raised. Resolved after a few days.
ACUTE RESPIRATORY FAILURE 10/29/2021 ANEMIA ACUTE HYPOXEMIC RESPIRATORY FAILURE 10/29/2021 ANEMIA
AST 60 (0-37), ALT 146 (0-40) 3 days after vaccination.
chills that progress to shaking; chills that progress to shaking; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills that progress to shaking) and TREMOR (chills that progress to shaking) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills that progress to shaking) and TREMOR (chills that progress to shaking). At the time of the report, CHILLS (chills that progress to shaking) and TREMOR (chills that progress to shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant and treatment details reported.