chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This nurse reports that this 6 year old male consumer received H1N1 vaccine, 0.5mL, at a public health clinic on 08Nov2009.The patient&#8217;s relevant medical history includes no previous allergic reactions to H1N1 vaccine or seasonal flu vaccines; no allergy to eggs; he has a history of asthma.  On 08Nov2009, within 30 minutes after the immunization, he broke out in hives and continued to have hives off and on for two weeks. The child did not require any additional laboratory testing or any additional medications. The mother of the child refused further immunization with N1H1 vaccine. It is unknown if the child continues to experience hives.
This spontaneous report was received from a certified medical assistant and refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with PNEUMOVAX 23, lot number L035687, expiration date 16-FEB-2017 and lot number L038522, expiration date 11-AUG-2017 (route was not provided). Concomitant therapy information was not provided. On unknown dates, there was incorrect product storage as PNEUMOVAX 23 were administered to an unspecified number of unspecified patients following a temperature excursion that was originally reported on 21-MAr-2016. The temperature was 62 F for 2 hours and 12 minutes. No adverse event was reported. At the time of the report, the patients' status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Anxiety attack. Medics cleared pt and pt walked out on own and asymptomatic.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; We had patients who were administered the vaccine that underwent temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021 at 4:35 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Oct-2021 at 4:35 AM, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was given.  No treatment medication was given. Reportedly, 280 patients received Moderna Covid 19 stored at minus 82 degrees Farenheight. On 19-Nov-2021 Moderna Covid-19 vials went from the super cold freezer to the refrigerator. It was stated that patients were given doses from vials that were stored in an ultracold freezer which was colder than they should had been. Excursion duration was 1 month. No vaccine state changes were noticed and the vaccine was never frozen   This case was linked to MOD-2021-402935 (Patient Link).
This spontaneous report as received from a registered nurse refers to five patients of unknown age and gender. Concurrent conditions, pertinent medical history, drug reactions or allergies were not reported. On an unknown in 2015, over the past two weeks, the five patients were vaccinated with improperly stored doses of (Merck) VARIVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse events reported. Concomitant therapies were not reported. The outcome of the event was unknown. Additional information has been requested.
I had my first shot of the vaccine on February 28th and experienced no side effects except a small bruise and slight, very slight soreness of the injection site and some swelling in my left arm where I've had lymphedema in the past. The swelling went away yesterday but this morning, I woke up with a round (3" in diameter) itchy, red hive adjacent to the site of the injection. It doesn't seem possible this could be a reaction to the vaccine (which I was delighted to receive) but I thought I should check and see. I'm scheduled for the 2nd shot on the 29th of March.
c/o SOB, severe chest pain, pt skin was clammy & pale;pt c/o feeling faint approx 30min p/vax;911 called epi given;
Onset of symptoms 11/17/09 5pm hives on trunk and extremities, progressed to generalized hives. Seen in ER and treated. Then seen by dermatologist, another ER visit, Dx erythema multiforme and serum sickness.
Wife said he hurt all over, had a fever and was nauseous. His arm was also sore and had a "knot" she said.
It was reported that a male pt received a Fluzone SV '99-'00 vaccination on 10/22/99. Reportedly, the next day, post vax, the pt developed a red rash over his entire body, along with ecchymosis and nosebleeds. Correspondence received on 12/1/99, states that the pt began taking vitamin K after a few days with a decrease of gum and nose bleeds. The pt refused to see the doctor, but reported the symptoms on 11/8/99. A fine macular rash with large ecchymosis was noted.
Pt reported that she had chills and fever the night she got the vaccine.  She took Tylenol and the symptoms stopped by the next morning.  She reported these symptoms on 11/10/2020 the day after the vaccine was given.  All symptoms except a headache had resolved at the time of reporting.  We recommended ibuprofen for her headache.
have a spinal tap done, because makes you feel so bad.; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included infection.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The physician said there had been people that had actually gone to the hospital and infectious disease doctors looked at them and they had a spinal tap done and could only come up with it was the shingles vaccine that had that made the patient feel so shitty, so bad. This case linked with US2021203774 and US2021203777, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021203774:same reporter US-GLAXOSMITHKLINE-US2021203777:same reporter
On day 14 after injection appeared a Red and hot spot/or rash looking lesion just below inspection area.  Symptoms were, fatigue, nausea, diarrhea first 24 hours then left, fever and chills, sometimes clammy hands and feet.
Lt arm, red, swollen, less on Lt side abd. area. Rt arm. Rx-Cephalexin.
About 5 minutes after receiving the vaccine the patient began having tremors, nausea, blurred vision, and inability to stand without the urge to vomit (resulting in dry heaving).  The patient laid down on the floor and vaccination staff proceeded to fan him and attempt to cool him off and keep him calm. This continued without much change over the course of about 30 minutes. As a precaution 9-1-1 was called and the patient was taken to the hospital by ambulance for observation and further evaluation.
Mother states the morning after vaccines given 1-16-04, temp 101F, deep red/swollen arm-arm enlarged elbow to shoulder, rash on arm/shoulder/neck and back and chest, deep red and thick runny nose and itchy eyes.  Mother called ER and tld to give Benadryl, which she did and symptoms decreased within 30 minutes, arm stayed swollen and less red another day or two, saw MD 1/20/04 for check up.
This spontaneous report was received from a medical assistant referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot# L042835, expiration date 19-AUG-2018; and lot# M001814, expiration date 15-OCT-2018) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 32 and 35 Fahrenheit degrees (also reported as 34.2 F) for a time frame of 4 hours and 45 minutes; digital data logger was involved. There was not previous temperature excursion for the vaccine. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA002328: US-009507513-1704USA003209:
Patient was in clinic today to receive booster shot of Janssen vaccine. Patient received first Janssen vaccine on 5/28/21. Patient requested a Janssen booster shot but was given a Moderna booster shot instead. Moderna booster was given before the 6 month period dictated by Moderna manufacturer and CDC.  No adverse events reported by patient. No follow on care needed for patient.
Patient arm red/swollen. Told to give BENADRYL q 6 hrs.
Felt dizzy and clammy. Sat with nurse for about 7 minutes and drank water. Felt better and went home.
received dose of that had expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 14-year-old female patient who received HBV (Engerix B) (batch number 722KC, expiry date 6th April 2022) for prophylaxis.   On 22nd June 2022, the patient received Engerix B. On 22nd June 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-JUN-2022 Reporter's Comments: The nurse reported that a dose of Engerix B was given to the patient and it was already expired. The reporter consented to follow up. Additional Supportive Information: The use of Engerix B dose which was already expired on 6th April 2022, which led to expired vaccine used.
FELT LIGHT HEADED; DISORIENTED; SWELLING OF STOMACH; SWELLING OF ARMPITS; SWELLING OF HANDS; ANXIETY; FEELS LIKE VERTIGO; This spontaneous report received from a patient concerned a 58-year-old  male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 (took 6-7 months to clear), and concurrent conditions included smoking, fatty liver, high triglycerides, dieting, and seasonal allergies. Patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered, 1 total to left arm on 09-MAY-2021 for prophylactic vaccination. Concomitant medications included loratadine for seasonal allergies. On 09-MAY-2021, 30 minutes after vaccination the patient felt light-headed and disoriented and he drove to the hospital where he consulted in emergency room and did blood work, and did X-ray of heart and lungs. They put him on IV (intravenous). Patient was admitted for 4 hours and discharged. On 09-MAY-2021, the patient also experienced swelling in both hand, stomach and in his armpits. Since after discharge patient felt disorientated sometimes. The patient felt nervous and also felt like vertigo. Patient was completely disoriented and felt dizzy when he was walking (prior day of reporting). He still had swelling on hands and recovered from swelling on stomach and armpits. Patient felt anxious sometimes and could not walk and he mentioned it could be partly due to unemployment and overwhelming medical bills. The patient mentioned that he had covid-19 in OCT-2020 which was pretty bad that made him decided to take vaccine. He was worried how long these symptoms will persist at a time and unemployment added to his anxiety. He also mentioned about seeing doctors to rule out other rational other than the vaccine. Patient had lab test during his emergency room visit. Laboratory data included: Blood test (NR: not provided) as Not reported, and X-ray of heart and lungs (NR: not provided) as Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of stomach, and swelling of armpits in MAY-2021, and had not recovered from felt light headed, disoriented, feels like vertigo, anxiety, and swelling of hands. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210556773 -Covid-19 vaccine ad26.cov2.s-Felt Light-headed, Disoriented. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY  V0: 20210556773 -Covid-19 vaccine ad26.cov2.s-Swelling of stomach, swelling of armpits, swelling of hands. 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).
Feeling discomfort; swelling and redness around left nipple/pectoral; swelling and redness around left nipple/pectoral; swelling and redness around left nipple/pectoral; my lymph nodes that are swelling; nipple of the breast does have discomfort; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left bicep on 23Apr2021 at 12:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Apr2021 at 10:00, roughly 72 hours later, the patient felt discomfort, swelling and redness around left nipple/pectoral. Within the last 24 hours symptoms remain and was not sure if this was common. The patient believed it was his lymph nodes that are swelling but by the nipple of the breast does had discomfort. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown, if the patient received any treatment for the events. The clinical outcome of the events felt discomfort, swelling and redness around left nipple/pectoral and believe it was his lymph nodes that are swelling but by the nipple of the breast does had discomfort was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 11-JAN-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0975AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
- Vaccination received at shot clinic o/a 10 Apr - Injection administered by male,  (unsure of name) - After I inquired whether or not the Anthrax booster usually resulted in sore muscles, the technician verified it did and I requested the injection in my left shoulder - No other vaccinations received that day (not since 19 Feb 2021 according to my recollection) - Injection seemed normal other than being placed slightly higher than usual into left deltoid - The evening of the injection, I pointed out a swollen ?welt? on my L shoulder to my spouse as I could visibly see it looking in the mirror and comparing the L to the R deltoid - The swollen area was approximately 1/3 from the top of the deltoid/shoulder, was sore and inflamed, but not noticeably discolored  - The following day, the shoulder muscle was sore and the injection site was still swollen, but I didn?t show any other symptoms (fever, inner-shoulder pain, etc) - Within the week of the injection, I developed pain in my shoulder similar to what I felt prior to my recent Right shoulder surgery to repair a torn labrum, rotator cuff and cartilage damage to my right humerus -- I would describe this pain as sharp nerve pain, or a pinching pain felt when the left arm moves/extends/reaches back (placing L arm second into a shirt sleeve, turning and moving objects with the left arm, drawing the left arm back, reaching for my upper back with the left arm, etc) -- This Left shoulder pain continues approximately 2.5 weeks after the injection -- I am treating the pain with OTC anti-inflammatories (Motrin, Alieve) and when home/not out of town for my work, 1x/daily Rx I was issued by my orthopedic surgeon following my R shoulder operation (Celecobix 200mg, on-file); I am also performing shoulder exercises I learned during PT before and after my operation
Three days after immunization, developed scaling all over body. No Petechiae. Low-grade fever. No mucosal lesions. Mild Stevens-Johnson like scaling.  RXed with Prednisone
4 pm severe headache (left temple until 10pm. At 10pm lost hearing in both ears for 15 minutes followed by 0-5% hearing with tinnitus for 24 hours.  Fever  starting at 9 am next day until 11pm that night.
Felt dizzy so we placed her on a gurney for about 10 and then she felt better BP  was 118/74
HYPOXIA 2/21/2023 &  1/22/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Unsure on onset time, but pt got the slight raised, red rash that can occur in 1 of every 3 people that receive Zostavax injections.
Myalgia, Diarrhea, NauseaVomiting chills Narrative:   Other Relevant History:
Information has been received from a pharmacist regarding to a 56 years old male patient. On 30-AUG-2012, the patient was vaccinated with 0.65mL of a dose of ZOSTAVAX, subcutaneous in right arm (lot # 670980/0731AA, expiration date 17-AUG-2012). No other co-suspects were reported. No concomitant medications were reported. On 30-AUG-2012, the patient was vaccinated with expired ZOSTAVAX. No adverse effects reported. Patient's outcome was unknown. Additional information is not expected.
First injection only had arm muscle pain. Second shot had severe cold chills all night with bad headache,  muscle aches and mild fever of 100.8 degrees F. Very sore muscle at injection point and redness about 6 inches around three days later.
This spontaneous report was received from a pharmacist via a company representative and refers to a 73 year old female patient. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 21-JUL-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque forming units (PFU) vial (lot # M015925, expiration date, exact dose and route of administration were not reported) in the pharmacy. On an unspecified date in July 2016, the patient developed a shingles rash on the back of the arm and chest and she returned back to the reporter's pharmacy on 29-JUL-2016 due to the event. The patient was seen at urgent care clinic for the rash and she was prescribed an unspecified antiviral medication. The patient's rash recovered after completion of the antiviral treatment on an unspecified date in 2016. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
tested positive after her first dose; tested positive after her first dose; This is a spontaneous report from a Pfizer-sponsored program a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 28Mar2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. In2021, the patient tested positive after her first dose (drug ineffective).The caller was scheduled for the second dose on 18Apr2021.Caller wants to reschedule her second dose 19Apr2021.The patient underwent lab tests and procedures which included sars-cov-2 test: positive in 2021. The clinical outcome of the event was unknown.   Follow-up (18Apr2021): This follow up report contains no new safety information.   Information on the lot/batch number has been requested.
Information was received from a physician via a Company Representative regarding a patient of unknown age and gender. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # N003997 (dosage, frequency and indication unknown). It was reported that the patient experienced an infection at the injection site two days after receiving PNEUMOVAX 23. The outcome of the event was unknown. Causality assessment was not provided. Additional information is not expected as there was no contact information for the physician.
Administration was administered at the correct location. When observing the administration site, there was a small lump with bruising around the injection area. The patient did state when I followed up on the phone an hour after administration that the lump is still there with bruising. Pt did state their is no pain or irritation. Pt has stated no issues with breathing, or anaphylaxis type reactions.