chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects; patient was administered one dose ofROTATEQ which was improperly stored; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.      On an unknown date in 2020 (reported as "sometime after at the end of October 2020"), the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose and route of administration were unknown; lot number 1660989, which has been verified to be valid, the expiration date was reported and validated as 15-APR-2021) as prophylaxis (product storage error).   The suspect vaccine was exposed to a temperature of 9 degree Celsius (C) for a time frame of 50 minutes, as recorded by digital data logger. Previous temperature excursion was 11 degree C for 1 hour. No adverse effects were reported.  This case was initially considered as a non-valid case due to the lack of patient's identifiers.  Follow-up information has been received from the nurse on 04-DEC-2020. The patient's name was provided. The case becomes valid. Additionally, the reporter stated "the patient was contacted after receiving the vaccine and they are "good" and there was "no adverse event".
Approximately 2 hours after vaccines were administered, patient began having fairly severe symptoms of dizziness, nausea, and racing heartbeat. She did not contact the pharmacy during this time, she recalled this reaction at the time her second dose of Gardasil 9 was due and we called her for a reminder. According to her report, she had to lay down to rest for about 1 hour due to the symptoms, after which they decreased in severity but were still present for 4-5 days. She was advised to contact her primary provider regarding risk/benefit of future doses of this vaccine.
Pt developed  a red rectangle about 2inchesx 4inches around the middle of the upper arm (bicep/tricep area) on both arms and applied ice to the area. Still red today when the came back into the pharmacy today 5/31/23, recommended they go to their doctor to have it looked at.
had a higher concentration, build up of mucous and phlegm; It has been more difficult to breathe every morning.; This spontaneous case was reported by a patient and describes the occurrence of PRODUCTIVE COUGH (had a higher concentration, build up of mucous and phlegm) and DYSPNOEA (It has been more difficult to breathe every morning.) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 immunisation.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCTIVE COUGH (had a higher concentration, build up of mucous and phlegm) and DYSPNOEA (It has been more difficult to breathe every morning.). At the time of the report, PRODUCTIVE COUGH (had a higher concentration, build up of mucous and phlegm) and DYSPNOEA (It has been more difficult to breathe every morning.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment information was not provided.  It has been more difficult to breathe every morning and is taking him 3-4 hours more than usual to get ready in the morning. He has not taken any treatments.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
On 12/6 developed redness, itching at site on left thigh at site of GARDASIL vaccine. Progressed to about 5" swollen area, no drainage or pustule, no fluctuance. Seen in office 12/7, area warm and mild erythema, mild tenderness but mostly itchy. Felt to be local allergic reaction and not cellulitis.
Client received the Pfizer COVID-19 vaccine and during the post-vaccination wait time he complained of itching around the eyes and face, and felt that his face was swollen. He stated that he had an anaphylactic episode in the past involving peanuts and nut trees, and because of that, he carries an epipen. "911" was called and his vital signs were as follows: BP=173/117; Pulse=76. Engine 205 responded to the call and evaluated the client, but was not transported to the hospital. Client did not receive 2nd dose of the Pfizer vaccine.
itchy rashes on leg; burning rashes on leg; few hours after vaccine, rashes over legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rashes on leg), BURNING SENSATION (burning rashes on leg) and RASH (few hours after vaccine, rashes over legs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced RASH PRURITIC (itchy rashes on leg), BURNING SENSATION (burning rashes on leg) and RASH (few hours after vaccine, rashes over legs). At the time of the report, RASH PRURITIC (itchy rashes on leg), BURNING SENSATION (burning rashes on leg) and RASH (few hours after vaccine, rashes over legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report was received from a registered nurse refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with GARDASIL (dose and frequency was not reported) intramuscular injection. The nurse reported that the PNEUMOVAX23 was exposed to temperature of 11 C. On an unknown date in December 2012, there were 13 excursions for a total time of 112 hours. On an unknown date in January 2013, there were 9 excursions for a total time of 72 hours. On an unknown date in February 2013, there were 11 excursions for a total time of 96 hours. On an unknown date in March 2013, there were 7 excursions for a total time of 56 hours. On an unknown date in April 2013, there were 12 excursions for a total time of 120 hours. On an unknown date in May 2013, there were 7 excursions for a total time of 65 hours. On an unknown date in June 2013, there were 6 excursions for a total time of 49 hours. On an unknown date in July 2013, there were 11 excursions for a total time of 104.5 hours. On an unknown date in October 2013, there were 2 excursions for a total time of 17 hours. The nurse stated that the doses were administered to unspecified number of patients on unspecified dates throughout the year. No adverse effects reported. Action taken with GARDASIL was unknown. The outcome of the event was unknown. This case is linked to the same reporter linked cases 1401USA000188 and 1401USA000217. Additional information has been requested.
sinus cold; This case was reported by a consumer via call center representative and described the occurrence of head cold in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th February 2020, the patient received Shingrix. On 28th February 2020, 3 days after receiving Shingrix, the patient experienced head cold. On an unknown date, the outcome of the head cold was unknown.   It was unknown if the reporter considered the head cold to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient woke up with a sinus cold on day of reporting. His call was disconnected during the early phase of the conversation. The reporter did not consent to follow up.
Dizziness - headache - rash - swelling in the arm - tachycardia - elevated high arterial pressure 158/88 mmHg, HR: 109 pm - no history of HTN - after 25 min
This spontaneous report was received from a male patient of unknown age who was reporting on himself. No information was provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies. On 17-MAY-2017, the patient was vaccinated with the first dose of GARDASIL injection (exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 14-AUG-2017, the patient received the second dose of GARDASIL injection (exact dose, route of administration, lot # and expiration date were not reported). On 23-JAN-2018, the patient was vaccinated with a dose of GARDASIL 9 (exact dose and route of administration were not reported; lot # N015087). That was the third dose of the human papillomavirus vaccine received by the patient. No adverse effects were reported.
On 04/05/21, the patient came in for her second dose and reported that about 20 minutes after receiving her first dose, she began to experience facial numbness on the left side of her face to include the cheek, temporal, and left side of forehead. She states that she never reported the incident until now and did not take any OTC medications, such as Benadryl. She states that facial numbness subsided the same night.
Pt. suffered Syncopal episode shortly after receiving the vaccine shot. Pt. was driving from injection area to observation area and had a minor traffic accident due to syncopal episode.
This case was reported by a physician and described the occurrence of injection site pain in a 66-year-old male patient who received SHINGRIX. Concomitant products included FLOMAX, Aspirin and SYNTHROID. On 24th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, fever and tenderness. On 24th April 2018, the patient experienced submandibular mass, headache and muscle pain. On 26th April 2018, the patient experienced loose bowel. On an unknown date, the outcome of the injection site pain and tenderness were unknown and the outcome of the submandibular mass, loose bowel and fever were not recovered/not resolved and the outcome of the headache and muscle pain were recovering/resolving. It was unknown if the reporter considered the injection site pain and tenderness to be related to SHINGRIX. The reporter considered the submandibular mass, headache, muscle pain, loose bowel and fever to be almost certainly related to SHINGRIX. Additional details were provided as follows: On 24th April 2018, in the noon the patient received SHINGRIX in the left deltoid and in the evening (several hours later), the patient experienced submandibular mass, headache and muscle ache. Two days after vaccination, the patient experienced loose bowels.
my 2 doses should be tomorrow June 12th but I can't travel again till July 10th; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (my 2 doses should be tomorrow June 12th but I can't travel again till July 10th) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (my 2 doses should be tomorrow June 12th but I can't travel again till July 10th). At the time of the report, PRODUCT DOSE OMISSION ISSUE (my 2 doses should be tomorrow June 12th but I can't travel again till July 10th) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
I started having racing and hard heart beats that progressed into pain in my center chest, left chest area and left shoulder over weeks and months.  Sometimes aggravated by situations other times for no reason at all.  I put them off as to much caffeine, pain from a shoulder replacement, anxiety aggravated by menopause, etc.  I mentioned it to my primary doctor in November and that kicked off a series of test.
No additional AEs; MMR II lot expired on 7/30/22 and was given to patient today, 8/3/22; This spontaneous report was received from a registered nurse referring to a 16-year-old male patient. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On 03-AUG-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) (0.5 mL, once, lot #T025930 and expiration date was reported as 30-JUL-2022 (also reported as 30-JUL-2022, but upon internal validation established as 30-JUL-2022); strength, route and anatomical location were not reported) for prophylaxis (expired product administered). The patient was inquiring information pertaining to the administration of expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (M-M-R II). No additional adverse event was reported (no adverse event).
Home tested  6/28/2022 -  negative. Then home tested the next day 06/29/2022  and tested positive. Went to ER as I have Monoclonal Antibodies, compromised Immune System. Decided not to do a Chest X-ray. Part of my ailments was that I had been having a severe sore throat, and it's healed now but my vocal cords aren't the same. My voice is very raspy.
very sore left arm for 4 days. No energy, shivers, muscle aches, mild ear ache with ringing in ears, light headed for 13 days
tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (Severe allergies).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jul-2021, the patient experienced COVID-19 (tested positive for Covid). At the time of the report, COVID-19 (tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. No treatment medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
Pt reports h/a and body aches 4 days post Zoster vaccine. Pt states 7 days post Zoster vaccine red, itchy, weeping, crater-like sores started appearing.  Shooting pain in left wrist x10 min's.  Spots/areas still appearing.
I had left arm pain and swelling for 3 days following the injection. By the 20th symptoms were more tolerable and mild, the 22nd I had Bell?s palsy and left side paralysis and had to go to the ER. Now I?m on antiviral medication.
Patient received expired Hep B vaccine on 12/2/2021. The vaccine expired on 11/12/2021. Patient is asymptomatic from following expired vaccine administration.
Vaccine administered Sunday at 2PM, severe chills/fever within 72 hours status post vaccine administration.  72 hours after: venous distention on vaccinated arm from the inner upper arm to wrist. Blood pressure <130/80. no fever, no chills. Thursday okay.  Friday night at around 9PM, sudden feeling of loss of consciousness but without actually losing. Huge gush of warmth and blood to brain. After episode, cold and sweaty hands. Both arms had distended veins visible.  Saturday morning, back to normal. no venous distention, no feeling of fainting. Saturday night at 10:30PM, BP 155/99, HR 88, distention of veins on both arms. 11:40PM, bilateral leg swollen, no pain, no signs or symptoms of VTE, no SOB.  Sunday AM: blood pressure normal, swollen legs disappeared, achy and sore knee and hip joints bilaterally.   Still monitoring signs and symptoms.  PCP advised to take Aspirin 81mg daily.
Muscle Pain; Pain in arms; Pain in the knees; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced muscle pain, pain in arm and knee pain. The patient was treated with prednisone. On an unknown date, the outcome of the muscle pain was recovering/resolving and the outcome of the pain in arm and knee pain were unknown.   It was unknown if the reporter considered the muscle pain, pain in arm and knee pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine on left arm. The patient experienced muscle pain, pain in arms and knees after receiving Shingrix vaccine. The patient was prescribed prednisolone. Consent to follow up was provided. No further details were provided. This case was linked to case US2019AMR120937, due to same patient.
This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 66-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site erythema (refer case US2018224296). On 10th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In December 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities and injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the erythema of extremities and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities and injection site pain to be related to SHINGRIX. Additional details were received as follows: At the noon, the patient received SHINGRIX in the left arm and has redness and soreness again. The redness was above the actual injection site. The reporter said it was more red at the time of reporting than it was an hour before the time of reporting. The patient did not consent to follow up.
Pt was seen at ER 5/16/04 after febrile seizure witnessed at home.
I underwent a PCR test on 1/19/2022. On 1/22/2022, I received a text message alert that informed me I had tested positive. I self-isolated at home for about a week afterwards. I normally do Wim Hof exercises to help with my breathing, as I have asthma. I noticed during this time, though, that my exercise performance declined a little. More specifically, I was able to breathe less deeply for less time. I'm normally able to hold my breath for 2 minutes, but during my illness, I was only about to hold it for 45 seconds or less. Overall, I felt weaker and more fatigued. I normally exercise, but I didn't that week. I took all of my usual supplements, but I refrained from taking the Valacyclovir I usually take, since it is an immunosuppressant.
The day after I had the injection April 25, 2021, I was extremely lethargic and very uncomfortable body aches. I was very nonfunctional that day so I just laid around and visited some family that was over. This went on for about 14hour out of that day. Over the next few days, I felt very fatigue. Around the 28 of April, I started having shortness of breath considerable pain around my chest and rib cage area. I was very short of breath during any activities just basically miserable. I dealt with it because it was not not constant, and it would come and go. On May 25 I finally visited PCP, there were no abnormal breath sounds or nothing that would indicate I had a infection. At that time, she opted to put me on a albuterol in haler as needed. Then she ordered a Pulmonary Function test (June 16). There were some issues with getting the test done between my PCP and the lab. Based off the results my doctor instructed me to keep using the inhaler she prescribed. As the weeks progressed the sob improved but I would still have sob moments that were sporadic. I still was stiffening from pain in my ribs on and off until late summer of 2021. Over time the pain decreased until it completely went away. As of today, I am doing okay with my breathing and the chest pain has resolved. In the first part of Sept. I began to have headaches in the left postrenal side of my head. I had muffled hearing ear sensation -like something was crawling in my ear or that it was full with something. I saw my doctor again Oct 14; my ear checked out normal nothing that she saw from the exam she prescribes a weeklong prednisone. The doctor felt it may be related to allergies. Within three weeks my ear started to feel better. I continued to feel like there was something in my ear along with headaches. The doctor did refer me to a ENT specialist. Continued to be a problem -headache mostly around my ear and sensation of something inside my ear. ENT- Specialist -Feb 28, 202I  based on the exam and my symptoms-Otologic Migraines. The issue with my ear progressed along with blurred vision, unsteady balance; dizziness; I experience some loss of hearing; This was all persistent up until a month ago and it finally went away.
PAtient felt lightheaded immediately after initial dose of Pfizer COVID-19 vaccination.  Patient reported having been extremely anxious about vaccination prior to administration.  Had some pain at injection sight then felt lightheaded.  No syncope, no shortness of breath and no other symptoms.  No evidence of allergic reaction present on examination.  Awake, alert, strong  pulse, no rash, oropharynx clear, airway patent, no erythema.  Reaction attributed to a vasovagal response to the injection related to anxiety.
This spontaneous report as received from a pharmacist refers to a 75 year old female patient with breast cancer in remission and allergy to amoxicillin. The patient's medical history included breast cancer. On 09-MAY-2014 the patient was vaccinated with ZOSTAVAX (19400 PFU, dose 0.65 ml, subcutaneous). Concomitant therapies included MYRBETRIQ. On 13-MAY-2014, the patient experienced pinpoint, dense rashes on her toes, mid-shin and continued to spread. The outcome of pinpoint, dense rashes on her toes, mid-shin and continued to spread was reported as not recovered. Causality assessment was not provided. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report was received from a physician via company representative, regarding an 11 year old female patient. No concurrent or historical condition was reported. On 26-AUG-2015, the patient was vaccinated with the first dose of GARDASIL, Lot number, expiration date, dose, route and anatomical location were not reported. Concomitant medications included unspecified polio vaccine and an unspecified meningococcal vaccine. ON 26-AUG-2015, the patient had syncope after receiving the first dose of GARDASIL. The patient sought medical attention at physician's office. No further information was reported. At the time of the report the outcome of syncope was unknown. Additional information has been requested.
fever (not confirmed) shaking, sweats, chills, weakness, muscle aches, soreness in the diaphragm, L arm site soreness. Abdominal cramping/discomfort. Seasonal vaccine and H1N1 vaccine were done on the same day. Client has soreness in the L arm today(1/28) and diaphragm soreness which he relates to cough onset.
Chest pain and tightness within 3-5 minutes after shot. Very lethargic and weak within 15- 20 minutes. Rescue called. Transported to er. Hives started about an hour after shot along with stomach pain. Epi pen and Benadryl given. Felt better afterwards.