chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Pfizer Covid  vaccine. Complaints of "throat closing" and "hard to breathe." Taken to EMS area by wheelchair, transfers self to cot. VS taken, 99 percent O2  Sats on RA.  Resp: 16, BP: 98/72. Lungs clear. No audible wheezes. Patient reports this has happened before when she eats different types of fruit, kiwi, bananas, watermelon and avocadoes.  Reports she usually is given a 1/2 tab of Benadryl by parents. Father confirms she is given 1/2 of a 25 mg tab.  This nurse offered Benadryl. Father declined. Will administer at home,  States "I'll give her one when we get home.  We only live like six minutes from here."  Remains in observation until 1905.  Ambulates self out without any further complaints. Father present throughout incident..
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with doses of improperly stored ZOSTAVAX injection, lot # L012039, expiration date: 07-JUL-2016; lot # L000448, expiration date: 08-MAR-2016 (dose, route and site of administration were not reported). No adverse effects were reported. Doses of ZOSTAVAX were administered following a temperature excursion at 25 degrees Fahrenheit for 15 hours and 20 minutes on an unknown date (also reported as on 01-OCT-2016). There was no previous temperature excursion. This is one of two reports received from the same reporter. Additional information has been requested.
Pruritic rash all over armpit. No SOB, No N/V 10-15 min post COVID # 3 shot. Pruritis head all over body to groin, then on feet, hives, lip swelling, tightness and chest epigastric pain. Treated with Benadryl 50 mg, Loratadine 10mg . Then pulse ox dropped to 91%. Lightheaded, dizziness, flushed hot, clammy and shaken.  14:33 138/78 95 99% 16 Benadryl 25mg 14:43 Benadryl 25mg 14:44 Loratadine 10mg 14:46 97/106 15:08 120/60 91% 58 15:35 110/90 98% 91 D/C 16:00 to home.
a gradual loss of taste since completing her Covid vaccine doses; This is a spontaneous report from a contactable consumer (patient's son) received via a sales representative.   A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced a gradual loss of taste since completing her Covid vaccine doses. It has been 4-6 weeks post 2nd dose. Event took place after use of product. The outcome of the event was unknown at the time of report.  No follow up attempts are needed. No further information is expected.
pt recv vax 11DEC96 & & 1JUL97 pt presented to a MD office w/chickenpox p/being exposed to chickenpox on 16JUN97;pt recovered;
Headaches; low fever; Tiredness; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of an adult age group received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 26Mar2021 at 12:15, as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, asthma, anxiety and attention deficit hyperactivity disorder (ADHD). The patient was not allergic to medications, food, or other products. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE) and sertraline (SETRALINE). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 05Mar2021 at 12:15, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks, prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 18:00, the patient experienced headaches, low fever, tiredness and diarrhea. The patient did not receive any treatment for the reported events. The events did not result in a doctor or other healthcare professional office/clinic visit. The clinical outcome of the events headaches, low fever, tiredness and diarrhea were resolved at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Woke up the next morning felt strange and left hand swollen badly. Shot was in left arm. Have been depression free for 2 years no meds. Ever since shot depression has returned with a vengeance. I have been very irritable. But I can't shake myself out this depression I'm constantly tired in bed by 7pm every night. It has seriously affected my life.
(R) deltoid arm/swelling within 24 hours, seen 3 days later decreased swelling and pain. 5 cm x 5 cm of erythema, warmth.
p/vax pt devel an inj site rxn characterized by redness, tenderness & swelling extending to the elbow;
Pt received Gardasil vaccine at 9AM. Called at 4PM complaining of nausea, vomiting, and left side headache with left orbital pain
Cold; Arm feels like it is sore; Body is achy; Took my temperature and it was 101 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), PAIN IN EXTREMITY (Arm feels like it is sore), MYALGIA (Body is achy) and PYREXIA (Took my temperature and it was 101 degrees F) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced NASOPHARYNGITIS (Cold), PAIN IN EXTREMITY (Arm feels like it is sore), MYALGIA (Body is achy) and PYREXIA (Took my temperature and it was 101 degrees F). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Cold), PAIN IN EXTREMITY (Arm feels like it is sore), MYALGIA (Body is achy) and PYREXIA (Took my temperature and it was 101 degrees F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 f (High) 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Patient states immediately after vaccination she "felt vision was off". Returned to worksite at approximately 9:00 am and noticed bilateral pupils were pinpoint and had a slight headache,  felt "vibrations" in body like a low blood sugar feeling and fogginess of brain. The next day, Feb. 25th, she returned to work feeling the same and blood pressure reading was 180/101 per school nurse.  States last blood pressure taken at doctors office was 2 weeks ago with result of 118/72. She states she started to feel better around 9:30 am the next day, Feb. 25th except for the blood pressure being higher than normal. Consulted her fiancé who is a medical doctor. Blood pressure reading on 2/26/21 at 7:30 am was 137/92 with no other symptoms expressed.
Case number PHEH2013US021603 is an initial spontaneous report received from a pharmacist on 15 OCT 2013. This report refers to a patient of unknown age and gender. This patient was vaccinated with an expired dose of a seasonal influenza vaccine (manufacturer and batch number unknown, expiry date: 20 JUN 2013) on 15 OCT 2013. No adverse event was reported following the maladministration.
Sore arm; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and HEADACHE (Slight headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and HEADACHE (Slight headache). At the time of the report, VACCINATION SITE PAIN (Sore arm) and HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication including high blood pressure medication and cholesterol medication was reported.  No treatment information was specified.
5 days after receiving the vaccine I was admitted to the hospital for acute appendicitis and had an emergency appendectomy. I?m unsure if it is related but there may be a connection so I?m reporting the event.
Woke up feeling horrible achy, hot, chills, nauseas, LIGHTHEADED that faded throughout the day took Tylenol.
Information has been received from a registered nurse concerning a white male who on 04-SEP-1997 was vaccinated with a dose of Varivax. Subsequently, the patient developed a generalized rash. It was not localized at the injection site. There were 50-200 lesions. It was unknown if the patient had a cough or fever. The patient was not hospitalized. It was unknown if the rash was MD documented/evaluated. Vaccine failure was noted. Additional information has been requested.
lack of energy; had a fever; This case was reported by a consumer via call center representative and described the occurrence of asthenia in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 10th November 2020, 1 days after receiving Shingrix, the patient experienced asthenia and fever. On an unknown date, the outcome of the asthenia was recovering/resolving and the outcome of the fever was unknown.   It was unknown if the reporter considered the asthenia and fever to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient and reported he received the second dose of Shingrix vaccine and next day morning The patient had a fever and lack of energy.  The patient reported he still has a lack of energy currently but feels a little bit better. The patient did not have lot number or expiration date information to provide. The reporter consented to follow up.
During the night the arm itched. During the morning started to develop hives in the area where the vaccine was placed, becoming a rush around the injection site.
Now is receiving breast cancer therapy; This spontaneous case was reported by a pharmacist and describes the occurrence of BREAST CANCER (Now is receiving breast cancer therapy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced BREAST CANCER (Now is receiving breast cancer therapy) (seriousness criterion medically significant). At the time of the report, BREAST CANCER (Now is receiving breast cancer therapy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received therapy for breast cancer.  No concomitant medications were provided.  It was reported that patient received the primary series of the Moderna Covid-19 Vaccine on Jan 2021 and Feb 2021 and the patient wasn´t immunocompromised at the moment of vaccination. but now receiving breast cancer therapy at the time of report and  also reports that patient wants to receive an additional dose of the vaccine.  Additional information regarding adverse event was not available at the time of report.  Company Comment:  This is a spontaneous case concerning a 68-year-old female with a medical history of 2 doses of mRNA-1273 in January and February 2021 who experienced the serious (medically significant), unexpected event of breast cancer at an unknown time and in an unknown relationship to the 2 doses of RNA-1273. Testing was not reported. Treatment is reported as chemotherapy. The outcome is probably ongoing as the patient is reported still being treated. Confounders are that the patient may have had the breast cancer before the vaccine and it is unlikely a cancer advanced enough to be detected could have been caused by the vaccine in such a short time period. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 68-year-old female with a medical history of 2 doses of mRNA-1273 in January and February 2021 who experienced the serious (medically significant), unexpected event of breast cancer at an unknown time and in an unknown relationship to the 2 doses of RNA-1273. Testing was not reported. Treatment is reported as chemotherapy. The outcome is probably ongoing as the patient is reported still being treated. Confounders are that the patient may have had the breast cancer before the vaccine and it is unlikely a cancer advanced enough to be detected could have been caused by the vaccine in such a short time period. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Administered a Dose of Heplisav-B that Underwent a Temperature Excursion; Initial Report Received 24-Sep-2021 and 27-Sep-2021  A nurse reported that a 71-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported.  The patient had no known allergies.   No concomitant medications were reported.  On 02-Sep-2021, a dose of HEPLISAV-B (Lot # 935840, Expiration Date 11-Sep-2022, NDC # 43528-003-01) was administered in the right deltoid.   It was reported that the HEPLISAV-B administered had undergone a temperature excursion.  No adverse reactions were reported by the patient at the time of report.   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
pt recvd vax; pt devel paresis of all four extremities; dx: transverse myelitis;
Per mom, patient had "exaggerated shiver" while sleeping four times during the night, after receiving immunizations. Patient shook his whole body. After shaking he tensed all muscles. Episode lasted about 5 seconds. He acted normal after episode. No cyanosis or any other symptoms besides arm pain from shots. Ordered EEG and mom is to observe.
States felt fine until that evening and then developed muscle aches and felt somewhat short of breath. Thought these were both side effects so went to bed. The muscle aches have resolved but is still short of breath, reports hard to take a deep breath today although he sounds fine on the phone as he speaks calmly and in complete sentences. He has no mouth swelling, there has been no rash or hives at all. He has no hx of asthma and doesn't believe anxiety is playing a role.  Pt concerned he may have gotten COVID from the vaccine.
Approximately 1.5 cm induration on lateral Lt arm. "Child appears to have had a reaction to recent immunization. Though it has been a month since her last immunizations which included Dtap, meningococcal, flu and HPV. She has continued to have a "lump" in her LT arm. There was initial erythema, but this has resolved and the child is not having pain at the injection site". Taken from office note 1/4/18.
Hospitalization - acute respiratory failure with hypoxia; COVID-19; Unable to ambulate; generalized weakness; confusion
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patient post temperature excursion; Moderna COVID-19 vaccine administered to patient post temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion).    Concomitant product use was not provided by the reporter.   It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.   No treatment information was provided.   This case contains information for the 83rd of 104 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:master case
Child was being held by her mother.  Nurse went to administer the vaccine in the left arm.  Patient moved and used her right arm to push the syringe out.  No vaccine was given.  Needle changed and administered full dose in the right arm safely.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 038A22A, expiration date 10.30.2022, was administered to patients/ Date(s) of administration of vaccine: 24Feb2023) and NO ADVERSE EVENT (No adverse event) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 038A22A) for COVID-19 prophylaxis.     No Medical History information was reported.       For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 038A22A, expiration date 10.30.2022, was administered to patients/ Date(s) of administration of vaccine: 24Feb2023).    Concomitant medication was not reported.     T
Pt came into pharmacy on 6/21/22 and wanted to speak with a pharmacist. She stated when she received her 2nd covid booster (moderna) the technician that gave the shot administered it too high and hit a nerve. Patient experienced a swollen imz site and complete immobility for 2 days and saw her dr on 6/20/22. Dr gave her exercises to increase her range of motion and pt is experiencing an improvement in range of motion.
I had no reaction to the shot except my arm was a little sore. About 1 week later, The area around the injection site itches and is a little pink and swollen. This lasted about  3 days. No treatment, seems resolved now.
After drawing pt blood and given pt 3 vaccines and DEPO-PROVERA 5 min later pt became dizzy. After 10 min pt then became unresponsive. She was cold and clammy. Unable to get a BP. IV was given. After given IV fluid we were able to get a BP reading. We then called EMS and pt was transported to the ER.
Broke out in hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke out in hives) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical reported history provided by the reporter.  Concomitant products included LOSARTAN, METOPROLOL SUCCINATE and ATORVASTATIN for an unknown indication.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced URTICARIA (Broke out in hives). At the time of the report, URTICARIA (Broke out in hives) had resolved.            The patient was treated with Lotions as a corrective treatment for the event hives (around my waist).   This case was linked to MOD-2021-061009 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up was received on 13-May-2021, the outcome of event updated.
I had to miss work for two days due to these symptoms: nasal congestion, fever of 100 degrees, joint pain, severe fatigue, severe dry mouth, muscle and body aches, nausea, pounding headache, also just feel "out of it"
No Adverse effects were reported; improperly stored doses of ROTATEQ, GARDASIL 9, and RECOMBIVAX were administered; This spontaneous report was received from a nurse referring to an 11-year-old female patient. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided.  On 07-MAY-2019, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) first dose, lot numbers R017251 (expiration date 04-MAY-2021) or N022718 with expiration date reported as 31-MAY-2020 which has been verified to be non-valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route and anatomical location were not reported), for prophylaxis. Then on 22-AUG-2019, she was vaccinated with a second dose of the vaccine.   Administered doses of vaccines experienced the temperature excursion above 47 degrees Fahrenheit (F) 9 degrees / Celsius (C) (highest temperature: 50.31 F) for 40 minutes and below 36 F / 2 C (lowest temperature: 0.13 C) for 152 hours. The digital data logger was involved in recording the temperature excursion details. There were no previous excursions reported.  This is one of several reports received from the same source.