chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administer expired vaccine to patients, after the manaufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manaufacture date of expiration.) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 immunisation.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manaufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manaufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. It was reported that vials had not undergone any temperature excursion.  Total of 102 doses were given from LOT 026C21A No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Nonsignificant follow-up information received on 08-Jun-2022.
Pt. returned to administering pharmacy complaining of a possible reaction. She indicated a large "goose egg" welp had appeared at injection site. The area was red and a little warm. Pt. also had red, rash on arms, feet, and calves. Pt. reported she is allergic to a lot of things (seasonal, aspirin). Pt. reported she had been using hydrocortisone cream.
Fri 4/9- got vaccine around 5:30 p.m. Sat 4/10 5:00 a.m. I had to go to work. I felt achy, my arm was sore where I got the shot, and I had a headache. I was achy all day off and on.  Sunday 4/11 I felt okay all day until around 10 p.m. At this time I noticed my throat was sore and swollen. I started coughing and feeling achy again. If I laid down I started to wheeze. I was very tired. Monday 4/12 I slept all day until 2:00 p.m. When I got up I felt achy and my throat was sore. I had a dry cough. I could not taste or smell. 4:15 p.m. went to my Doctor and was tested for Strep and Covid 19. I tested positive for Covid 19.
Narrative:  Reporter reviewed chart. Patient received Janssen vaccine on 5/28/21, was COVID positive on 7/10/21, and developed a pulmonary embolism that was treated with apixaban. Important to note that COVID can induce a hypercoagulable state that can precede DVT/PE. No reoccurrence of PE since.
Swollen face, eye lids , area below eyes and redness in eyes Water eyes, congested nose, slight headache
This spontaneous report as received from a registered nurse refers to a 14 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that on 31-JUL-2014 the patient received (Oka-Merck PROQUAD INJ, 0.5 ml, once, subcutaneously (lot number not provided), to "catch up schedule". It was reported that therapy was not discontinued. No adverse effects were noted. Additional information has been requested.
Information has been received from a physician concerning a 31 month old female who in approximately 1998, subsequent to receiving on dose of varicella virus vaccine live the pt experienced a breakthrough case of chickenpox on 11/17/99. The pt had sought unspecified unspecified medical treatment.
Arm slightly started to hurt four hours after shot. By 9:30, arm was very sore, unable to lift higher than a few inches. Slight headache during the evening. During sleep, developed fever, and had the chills and sweats all night. 6:00 am next morning, temperature read 99.6. Fever and chills continued until 3:00 pm. Also during this time, had extremely painful headache, fatigue, slight nausea, and occasional leg pain.  Arm continued to be very sore, very limited movement, and tender to the touch. Pain in arm also extended out to top of shoulder and back of neck. After 3:00, symptoms lessened and only had headache, fatigue, and arm/shoulder soreness. Next morning, only arm/shoulder soreness, but much less significant.
ORAL PROBLEMS; THROBBING PAIN IN THE RIGHT LOWER JAW GOES DOWN TO THE NECK; SHORTNESS OF BREATH; DIFFICULTY SWALLOWING; SWOLLEN TONGUE; EXTREME PAIN; WEAKNESS/SHE CAN BARELY STAND FOR 2 SECONDS; SWELLING UNDER THE TONGUE (GLANDS); This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced oral problems, throbbing pain in the right lower jaw goes down to the neck, shortness of breath, difficulty swallowing, swollen tongue, extreme pain, weakness/she can barely stand for 2 seconds, and swelling under the tongue (glands). Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, and Investigation (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the oral problems, throbbing pain in the right lower jaw goes down to the neck, shortness of breath, weakness/she can barely stand for 2 seconds, difficulty swallowing, swollen tongue, extreme pain and swelling under the tongue (glands) was not reported. This report was non-serious.
it was rpt fr consumer concerning pt who was vax in 1996 & on 30jan199 devel approx 40 skin lesion, fever, headache & ITCHING.
By 6 pm I was feeling sick/feverish - By 8 pm my eyes were red and bloodshot, which got worse as the night progressed; I also had the feeling like I was getting a cough in my chest but that did not materialize.  My eyes were sore and less red the next day, and I was fine after 48 hours.  A week after the shot my left arm hurt and was hard to lift just for the day.   **I don't know if I listed the correct flu vaccine that was used - I did not have that information
Patient received 0.5mL of Moderna booster vaccine instead of 0.25mL.
Approx 5 minutes after receiving HPV patient stated he needed to go to the rest room. Patient found in the bathroom having a seizure, stated by the front desk staff.  Patient found leaning against wall complaining that stomach hurt.  Patient was laid down and cool packs were placed on forehead and gatorade was given.  Patient waited 20 minutes without further symptoms.
July 16, 2019, On Jan 15, 2019 got Second Shingles shot by that evening got red bump, hives rash, around where I got shot. Jan-16-17, 2019 still had red bumps around shot area. Then on Jan 18, 2019 got more red bumps around shot and right side of Rib case. Started to take pictures of bumps. On Jan, 19, 2019 Went to ER got more hives rash all over body stomach, back, Upper Chest, Neck, Arms. Was told to just take Benadryl. Took benadryl the hives rash got a little better. But still getting out breaks. This our the dates of outbreaks Jan, 25, 2019 on my forearms. Jan 26, 2019 Neck shoulders, Jan 27, 2019 stomach. Jan-28, 2019 Neck face all over upper body. Jan 31, 2019 on hands. My hands would hurt I could not even make a fist. Feb 1, 2019 on Neck and stomach. On Feb 5, 2019 showed Dr. rash on neck and face told him I had gotten shingle shot. He prescribe me Prednisone 10mg 3 tabs for 2-days-2 tabs for 2 days then 1 tab for 2 days. Feb 6, 2019 still getting rash on neck stomach arms. Feb, 13, 2019 still getting rash on arms. The rash went away for a while on Mar-28, 2019 still getting rash on left arm. April 5, 2019 still getting outbreaks on left arm. May 18, 2019 still getting outbreak on left arm. May 29, 2019 still getting outbreak on left. June 12, 2019 left arm outbreak. July 16 2019, outbreak on left arm. This outbreak I get stay on my left arm for a couple of days. Then it take them awhile for them to disappear. it is a burning feeling when they come out on my left arm. Don't get them on my body only on left arm for know. Still getting on left arm where I got shot. Also was sent to see a Allergy Dr. For red rash bumps, on left Arm. On June 26, 2019 Dr. MD, Stated possible allergic reaction to shingle shot.
Weak; Light headed; Sweating bad; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), DIZZINESS (Light headed) and HYPERHIDROSIS (Sweating bad) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 01-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weak), DIZZINESS (Light headed) and HYPERHIDROSIS (Sweating bad). At the time of the report, ASTHENIA (Weak), DIZZINESS (Light headed) and HYPERHIDROSIS (Sweating bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not provided.
symptoms of flu; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case is linked to cases 2020SA317477 and 2020SA317467 (same reporter).  This case involves a female patient (age unspecified) who had symptoms of flu (Influenza like illness), when she received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had non-serious symptoms of flu (influenza like illness) unknown latency following the administration of INFLUENZA VACCINE.  The reporter stated that a person can have a reaction to the flu shot. She did her son did and she spoke to several of her friends that have had the same thing happened to them. They had all the symptoms of the flu.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Had pneumonia; Loss of smell; Loss of taste; received her first Moderna vaccine on 22JAN2021 and has not received second vaccine yet; Tested positive covid; Felt not right; A spontaneous report  was received from a consumer concerning herself, a 82-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of smell / anosmia, loss of taste/ageusia, had pneumonia, felt not right / malaise, tested positive for Covid and received her first Moderna vaccine on 22JAN2021 and has not received second vaccine yet/product dose omission issue.  The patient's medical history, as provided by the reporter, included high blood pressure and high cholesterol. Concomitant medications reported included medications for high blood pressure and for high cholesterol.  On 22 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced loss of smell, loss of taste, and had pneumonia. The event, pneumonia, was found to be medically significant. On 03 Mar 2021, the patient was not feeling right and on 04 Mar 2021 she was tested positive for Covid-19.  Treatment details included the use of some nebulizers and quarantine.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, loss of smell, loss of taste, pneumonia, felt not right, and tested for Covid-19 was unknown and of event and has not received second vaccine yet was resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded except for the events of COVID-19 and Pneumonia.  The events of COVID-19 and Pneumonia is unlikely related to mRNA-1273 since the vaccine does not contain infectious elements capable of causing infection.
chills; fever; nausea; sore arm; shortness of breath, along with sob on my daily morning walks; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0179), via an unspecified route of administration in the left arm on 30Apr2021 as dose 2, single for COVID-19 immunization (at the age of 69-years-old). The patient medical history and concomitant medications were not reported, patient was a healthy woman. There were no known allergies. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0162), via an unspecified route of administration in the left arm on 09Apr2021 14:00 as dose 1, single for COVID-19 immunization (at the age of 69-years-old). The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 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. Patient stated that she received her second dose of Pfizer Covid vaccine on 30Apr2021. On 15May2021, she did have the side effects of chills, fever, nausea for 24 hours along with a sore arm. Two weeks after the vaccine she noticed shortness of breath while climbing stairs in her apartment along with sob on her daily morning walks with her dog. Then (30) days later she noticed it getting worse, she had no underlying conditions, she did not suffer from this prior to the vaccine. She was not on any prescription meds. She was a reformed smoker, she quit 28Apr1998. The patient did not receive any treatment for the events. The clinical outcome for events was not recovered except recovered for chills, fever and nausea on 16May2021.  Follow-up attempts are completed. No further information is expected.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010m21a and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced MYALGIA (Sore arm). On 11-Feb-2021, MYALGIA (Sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Endoscopy: normal (normal) normal.         Relevant concomitant medications were not reported.  The treatment information was  not provided.
?Janssen COVID-19 Vaccine EUA? slight headache, cold chills during Thursday night, felt horrible on Friday and vomited entire day on Friday.
Palpitations & sweatiness within 5 minutes of vaccine and loose stools. Extremely sleepy at 8:48pm (usually sleep 10 or 11pm). Woke nxt morning 5am with horrible headache & had a low grade fever 96.5 degrees. Took two Tylenol. Lasted till 10:30am.
Irregular seizure-like episode clusters, onset four days after administration of first round of live vaccines and continuing regularly for four days. Final diagnosis of paroxysmal spells, specifically shuddering attacks.
Pt recv vax on 9/15/98; on 9/17/98 pt exp soreness, pain in RA, swelling, redness from elbow to shoulder in big patches, area very warm to touch.
9/23/17 After receiving influenza vaccination, client states that arm (L) began to swell and he experienced significant pain - pt states arm was swollen for approx 3-4 days, after he applied ice and took an over the counter medicine for pain, swelling decreased.
Hives started at injection site on upper right arm and spread down to elbow. Then hives appeared on left upper arm, not as severe as hives on right arm. Her throat, down by the base of her neck, started to burn as if she had swallowed something hot. A few hives appeared on her throat.  She took one Benadryl at about 7:10 pm. It was not getting better after 30 minutes so she took another benadryl. The throat burning went away after about 30 minutes and the hives went away about 20 minutes after the 2nd benadryl.
Developed hives same day of H1N1 vaccination no respiratory symptoms seen 12-22 with hives lungs clean treated DECADRON 4cm IM, PREDNISONE dose pack, BENEDRYL.
After receiving the vaccine, patient started to feel lightheaded. He then passed out and had seizures for 30 seconds. He then regained consciousness shortly after. No further reaction occurs 45 minutes after administering vaccine.
Patient indicated that one week after receiving her Shingrix vaccine she experienced a red rash on the arm she was given the injection. She says she rubbed alcohol on it and applied neosporin and it went away. She did not contact the pharmacy or her physician.
received the first dose of the vaccine on 17Mar2021, tested positive for Covid on 25Mar2021; This is a spontaneous report from a contactable consumer via medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 17Mar2021 I received my 1st Pfizer covid vaccine. On 25Mar2021 I was infused with Bamlanivimab after testing positive for Covid. The caller stated she reviewed what she had written and realized she wrote it wrong. She received the first dose of the vaccine on 17Mar2021, tested positive for Covid on 25Mar2021 and received this medication on the 25Mar2021 as well. The outcome of event was unknown.
Redness/pain/itching at shot sight; rash on shoulder to elbow and 1/2 arm circumference; whole body joint/muscle pain, including neck muscles; headache; dizziness; shaking/pulse racing; shivering; fever; stomach issues and nausea; swollen eyes; and extremely tired.
Fever; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Lot number: EN6204) at the age of 74 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fever"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Tiredness".  Additional information: Patient confirmed that he maybe have had tiredness after the first shot and maybe fever but that was it; this only lasted a couple days. AE did not require a visit to emergency room or physician office. No prior vaccination within 4 weeks, no AE's following prior vaccination and no additional vaccines was administered on Same Date of the Pfizer Suspect.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from the patient's mother refers to a 20 year old female patient. In approximately 2009 "four or five years ago", the patient had already completed the series of three GARDASIL injections (dose, route and frequency were not reported), given by her primary physician. On 16-APR-2014, the patient was vaccinated with the "first" injection of GARDASIL (dose, route and frequency were not reported), by her gynecologist. The patient's mother stated that the patient was not complaining of any adverse reactions at the time of the report. The patient did not seek medical attention. At the time of the report, the patient's outcome of "received an injection of GARDASIL after already completing the series of three" was unknown. Additional information has been requested.
Pt. had aut abdominal pain that required a emergency department  visit.  Pt. came to the pharmacy a week after and said to be ok.
ACHEY; CHILLS; FEVER; NAUSEA; TIRED; WEAK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.. No concomitant medications were reported. On 16-MAR-2021, the subject experienced fever. On 16-MAR-2021, the subject experienced nausea. On 16-MAR-2021, the subject experienced tired. On 16-MAR-2021, the subject experienced weak. On 16-MAR-2021, the subject experienced achey. On 16-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and had not recovered from fever, nausea, tired, weak, and achey. This report was non-serious.
Left facial weakness, inability to close left eye.   12/31/09:  ED Records received for date of service 12/28/09.  Dx:  Bell's Palsy.  Presented with facial weakness x 5 days with gradual onset, now constant.  Also facial weakness and difficulty with speech.  Eyedrops given, instructed to sleep with eye taped shut.
Mom states right leg is warm to the touch, but not red. Pt does complain of soreness to both injection sites. ER physician note: Vaccination reaction, initial encounter: new and requires workup. Impression: Inflammatory changes around vaccination site and right anterior thigh consistent with normal reaction in my opinion. I do not think that this is a silent process at this time. Edges marked with surgical pen, given diabetic status recommend close observation, recommended 2 day follow-up, and to return to the ED if significant extension of erythema beyond marked borders or fever/chills. -- d/c home with clear RTED instructions.
pt had redness, swelling, fagitue, and myaligas starting the day after injection.  Fatigue and myaglias have resolved.  Still has redness and swelling at injection site.  Treatment is pt reassurance as common adverse effect, warm compress, otc anagelsic
Severe reflux and absence Seizures started between 2-4 weeks of age.  Sandifer Syndrome was ruled out, she was treated for reflux and eventually did a series of EEGs. Diagnosed with epilepsy and started on Kepra. She was vaccinated per the CDC guidelines despite having epilepsy and symptoms continued to worsen. She received further diagnoses of CDKL5, infantile Spasms, and a large number of severe autism spectrum symptoms.
Patient started with a low-grade fever and chills this morning after receiving the vaccine around 5pm yesterday. Around noon he started vomiting numerous times. It was recommended he take EMETROL and he has not vomited since. Patient was advised to see doctor if symptoms continued more than 2 days.
Hep A given too early. Patient had no signs or symptoms from receiving the vaccination. Patient had no adverse events from receiving too early. Reporting that the Hep A was given too early.