chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4 1/2 hours after the vaccine my arm got red, hot and felt a little swollen, the band aid placed got really tight. I got the chills and started shaking, I developed a fever of 102, chills and fever broke in 36 hours. I developed a cough, congestion and wheeze, had aches and pains all over, rolled around in bed for 36 hours. The fever broke by 7am on Sunday morning the aches and pains especially lower back still continue. I took Acetaminophen 1000mg twice during my 36 hours .Severe symptoms appear to be over.
From initial information received on June 28 2005 from a health care professional regarding an adverse event, it was reported that an 18 year old male patient received a dose of Menactra, lot number U1494AB, administered intra muscularly in the left deltoid on June 18 2005. 10 days later, on June 28 2005, the patient experienced fatigue and swelling of the anterior cervical lymph nodes. He also complained of discomfort in his jaw area. He was seen by a physician and was treated with Tylenol or Motrin as needed. The patients recovery status is currently listed as unknown.
Administer 0.5ml dose to the patient instead of the indicated 0.3mL dose. Patient did not not any vaccine reactions.
Patient reported COVID-19 like symptoms including fever, cough, fatigue, headache, muscle aches, and congestion
Patient reported  that she was experiencing headache, dizziness, and a feeling of "disconnect" starting the day after vaccination and persisting for several days. Also, presented on the evening of 12/21/2018 to the pharmacist with what appeared to be a mild, but widespread rash on both arms. Patient says the rash started two days after the vaccine and is all over her body..
18 years old patient was administered Fluzone Quadrivalent High Dose, no AE; 18 years old patient was administered Fluzone Quadrivalent High Dose, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via the Medical Information (Reference number- 00370404) on 24-Nov-2020.    This case involves an 18 years old female patient who received a 0.7ml standard dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] once (lot number, expiration date not reported) via intramuscular route at unknown administration site for prophylactic vaccination (Product administered to patient of inappropriate age and overdose) on 11-Nov-2020.  Medical history, past medical treatment(s), vaccination(s), family history were not provided.  No other vaccine was administered concomitantly  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose (latency-same day).  Reporter stated that a staff member administered the incorrect doses due to not paying attention to what was being given and to who it was being given to and that there was limited information available. It was reported as Fluzone Quadrivalent High Dose medication error with 4 patients described as the patients being under the age of 65 at time of vaccination  It was a case of actual medication error due to incorrect dose administered.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
on 1/13/21 after the shot and stayed at rest area for 15 minutes, as we went outside , walking to the parking lot, I noticed a distinctive stinging pain on back of my right hand below thumb, I saw puff veins and a quarter-size lump that was very painful.  I took Tylenol and put on my arm-wrist wrap wrapping overnight, it started to get warm and red the next two day.  I called my primary physician  on Monday 1/18/21 and have a victual visit for 15minutes at 3PM. It is getting better as of now on 1/19/21.
Awoke on 7/23/13 with fussiness, poor PO intake and began vomiting.  Had blood flecks in stool in evening.  Was seen in ER and diagnosed with intussusception that was reduced with an air enema.
flu; Initial information received on 26-Oct-2021 regarding an unsolicited valid social media non-serious case received from a consumer or non-healthcare professional via.  This case involved a patient (unknown demographic) who experienced flu (influenza) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.   The patient medical treatment(s), vaccination(s) 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 and expiry date not reported] via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Aged care residents had been experimented on with flu shots since before 1980. I worked at one (1980-82); on the 1st night after the flu shots, 2 things happen: they all get the flu & some did not live through it. Why did young people need a booster, for more blood clots?"  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Ringing in ears followed by headache. Still have ringing in ears as of today, 5/12/2021.
Within 30 seconds of administering the vaccine the patient began to complain she was experiencing a reaction to the vaccine. She stated that she felt her mouth was beginning to get dry and felt lightheadedness. Provider immediately evaluated the patient. Patient begin to get very red in the face and was grabbing for her throat. She was making a clearing of her throat sound and nodded her head when asked if she was having trouble breathing. IM epinephrine administered within 4 minutes. The patient refused further medical evaluation and left the clinic against medical advice.
58y.o. female with history of OSA on BiPAP, asthma, chronic respiratory failure on 3 L home oxygen, anxiety, depression presented due to complaints of difficulty in breathing,. On admission vitals were stable.  Labs showed LDH 242, CRP 37.8.  COVID-19 positive Chest x-ray showed a hazy opacity in the left costophrenic angle likely artifact. Next day after admission patient became more short of breath was placed on BiPAP Paxlovid was stopped and started on remdesivir.   Patient completed remdesivir during the hospital stay.  Was started on On IV steroids later switched to p.o. on discharge at the tapered dose for asthma exacerbation.  Patient improved during hospital stay, was back to 3 L oxygen.  Patient says she has oxygen at home , also had a portable tank with her .  Discussed with pulmonary cleared the patient for discharge, will need to follow-up outpatient with pulmonary, primary care.
had some effects after the 2nd dose that lasted a day and a half; This spontaneous case was reported by an other health care professional and describes the occurrence of ADVERSE DRUG REACTION (had some effects after the 2nd dose that lasted a day and a half) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, 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 experienced ADVERSE DRUG REACTION (had some effects after the 2nd dose that lasted a day and a half). At the time of the report, ADVERSE DRUG REACTION (had some effects after the 2nd dose that lasted a day and a half) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had some effects after the second dose that lasted a day and a half. No Treatment informations were reported.   This case was linked to MOD-2021-344368 (Patient Link).
patient with past medical history of chronic kidney disease stage IV and diabetes mellitus who came to the hospital with abdominal pain. Nephrology recommended the patient to be on IV fluids as he is having urine output.  The patient's renal function improved and his pain was under control. The patient will be discharged and advised the patient to get urology evaluation as a referral from his PCP. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
I had a rash at the injection site and it was a circular rash, very red, itchy and  it was hot to touch. I used a warm compress and took Tylenol to lower my fever. It took a week to go away and made my arm very achy.
Information has been received from a physician concerning a 9 year old female who was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. Four to five days after vaccination, the patient experienced a pretty healthy case of chicken pox. It was described as a rash with greater than 50 lesions. Unspecified medical attention was sought, but no treatment was required. No product quality complaint was involved. Additional information has been requested.
Body aches and pains, severe headache, lack of appetite, lack of energy, started  Tuesday at 3:00 AM. Lasted about 24 hours!  Wednesday 3/24/2021 7: OO AM A LARGE red and swollen area appeared on left upper are! Redder are around injection site. Arm sore and heavy feeling. Rash was hive like. Mild itchiness! Rash present still on Thursday 03/25/2021. Beginning to feel better.
0.25ml Fluvirin given, rec >4 yrs.  No reaction.
Information has been received from a health professional concerning a 16 year old female who was vaccinated with Gardasil (date not provided). Subsequently, following the vaccination the patient passed out for 45 seconds, felt cold and was shaking. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from an other health professional and a physician concerning a 16 year old female who was vaccinated IM into the deltoid with an entire second 0.5ml dose of GARDASIL (date not provided). Subsequently, following the vaccination the patient passed out for 45 seconds, was cold and shaking. The physician reported that the patient experienced a syncopal episode with approximately 30 seconds of clonic activity and urinary incontinence. The physician mentioned there was no post ictal confusion. The patient did well with Trendelenburg and rest. The physician reported that the patient was ok for discharge after approximately 10 minutes of monitoring. Subsequently, the patient recovered from syncopal episode, urinary incontinence and clonic activity. No product quality complaint was involved. Upon internal review, clonic activity was considered to be an other important medical event. Additional information is not expected.
Rash noted to trunk of body 1/29/21 and then to neck and jaw line by evening. Zyrtec taken and that evening and Benadryl with no changes. Doses repeated filling day with no changes. To urgent care on 1/31/21 with covid and Flu negative and Strept also returned negative to be told likely viral and covid send off also obtained.
Joint pain, head-ache, muscular weakness, migraine, fast heart beats, trouble sleeping. The doses were on different dates: 2/9/04, (A) 12/16/2003, (B) 1/20/2004, (C) 7/12/2004.
Patient developed chest pain, shortness of breath, and fatigue approximately 10 days after receiving 2nd dose of Moderna vaccine. Patient describes symptom onset as acute, and came to hospital 2 days after chest pain developed, as it became more unbearable. Described chest pain as worse with leaning forward.
Pt. reports that she developed tailbone/sacral pain around 8 am on 4/13 after having received MMR vaccine at 0952 on 4/11/ 22 Pain progressively worsened and is making it difficult for her to walk. Pt. did not report her side effects to employee health clinic until 04/19/22.  She was advised to not receive any further MMR vaccinations and to consult with her Health care professional ASAP Upon investigation, pt.  states that when she came to the country in 2016, she was given about 7 immunizations together and had a similar reaction, but did not know which had caused it. Pt. denied any issues with MMR vaccine at the time that it was administered and only had listed Hep B vaccine and Augmentin as allergies.
patch was very hot; Patch  was  very hard; Upper arm (below the injection site)  developed a patch; Patch  was very red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (patch was very hot), INJECTION SITE INDURATION (Patch  was  very hard), INJECTION SITE RASH (Upper arm (below the injection site)  developed a patch) and INJECTION SITE ERYTHEMA (Patch  was very red) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 28-Apr-2021, the patient experienced INJECTION SITE WARMTH (patch was very hot), INJECTION SITE INDURATION (Patch  was  very hard), INJECTION SITE RASH (Upper arm (below the injection site)  developed a patch) and INJECTION SITE ERYTHEMA (Patch  was very red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (patch was very hot), INJECTION SITE INDURATION (Patch  was  very hard), INJECTION SITE RASH (Upper arm (below the injection site)  developed a patch) and INJECTION SITE ERYTHEMA (Patch  was very red) outcome was unknown.            Concomitant medication was not provided.   This case was linked to MOD-2021-176564 (Patient Link).
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX on or about 05-NOV-2013 (dosage, lot number, and route of administration unknown), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-OCT-2014, the patient was treated by a physician assistant for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as chronic herpes zoster, or shingles, and post-herpetic neuralgia. On or about 15-OCT-2014, the patient was further treated for ongoing and worsening symptoms of shingles and post-herpetic neuralgia, a condition of chronic nerve pain and damage secondary to herpes zoster infections. The patient was prescribed valacyclovir hydrochloride (VALTREX), gabapentin, lidocaine, lidocaine (LIDODERM), tramadol, and hydrocodone/acetaminophen for management of her painful symptoms and chronic pain. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Seen in clinic 1 week after vaccine 6-9-09. According to dad 1 day after receiving the vaccine her attitude changed she became compulsive, says she hears sounds in her head, desire to see people's private parts - has been crying. No fever, no headache no vomiting.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 62-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 31st October 2019) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 10th April 2018). On 21st July 2018, the patient received the 2nd dose of SHINGRIX. On 24th July 2018, 3 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: On 24th July 2018, the patient was diagnosed with shingles.
paralyzed waist down from it; Initial information received on 18-Nov-2021 regarding an unsolicited valid social media serious case received from a consumer or non-healthcare professional via Digital Media.  This case involves adult patient who was paralyzed waist down from it (paraplegia) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient medical treatment(s), vaccination(s) 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 and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious paralyzed waist down from it (paraplegia) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Additional information was reported never got one, only had flu once, but my gramma almost died three years ago from it. Hospitalized for four days and had a friend in college paralyzed waist down from it. No thanks. 30 percentage efficacy and a crapshoot at if the jab is the strain prevalent at the time.  It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.; Sender's Comments: This case involves an adult patient who had paraplegia after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
the liquid part of the Pentacel was given to a child, no AE; Initial information received on 31-Mar-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 4 months old female patient who received a dose of only liquid part from the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL](lot: UJ259AAA, expiry date: 14-May-2021) on an unknown date via an intramuscular route in the left rectus formoris on 30-MAR-202.  The reported lot number for DTaP-IPV component- Liquid vial Lot: UJ331AA, expiry date: 14-May-2021 and  ActHib component lot: UJ182AA, expiry date: 08-Mar-2021.  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PNEUMOCOCCAL VACCINE CONJ 13V (CRM197)) for Immunisation.  It was an actual medication error due to inappropriate reconstitution technique.  At the time of reporting, the patient did not experience any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
24 year old female who has completed a 90 minutes-minute observation period with the following signs and symptoms of an adverse reaction: other - nausea, vomiting, dizziness, hot flashes, weakness 20 minutes after  Pfizer-BioNTech COVID-19 vaccine # 1 in series administered. Action(s) taken: Vital sign at 1135 blood pressure ; 157/84, heart rate: 89, respiration ; 16, Spo2: 100% Repeat Vital sign at 11:47: blood pressure ; 146/95, heart rate: 96, respiration ; 16, Spo2: 100% Vital sign at 12:03: blood pressure ; 134/84, heart rate: 107, respiration ; 16, Spo2: 100 % Vital sign at 1215: blood pressure ; 142/87, heart rate: 97, respiration ; 18, Spo2: 100 %  1147: I called to the Urgent Care, spoke with Dr., recommended benadryl 25 mg po and continue monitor patient in the covid vaccination clinic. If patient symptoms do not improved to transfer patient to the urgent care or to the Emergency Room.  - 1150: emesis x 1 no blood on emesis noted - 1205: benadryl 25 mg po given, patient was able to tolerated well.   - Patient denies chest pain ,shortness of breath,  diarrhea, abdominal pain, difficulty swallow, headache, or vision changes - Patient was   able to tolerated small sip of water.  - Patient continue complains of dizziness, nausea, and unable to focus.   Patient was transfer to ER in no acute distress , report given to triage nurse  Patient advised to discuss second dose considerations with a clinician
Dizzy and nauseated on way home from store - started drinking water in case dehydrated. Went to bed early since still dizzy. Woke up around 1:30 AM and was nauseated and went to bathroom to throw up - passed out. Went to Dr in morning - had a fever. Tried to eat in morning - threw up. Dr did blood work - no issues found. Dr thinks from Flu shot and recommended pharmacy report to VAERS.
At approximately 9:30 pm on 02/26/21 (day 2) I noticed a lacy rash covering about a third of my left upper arm.  There was a swollen area under the skin.  Skin also felt warm to the touch.  By 9:30 pm the next evening (day 3) the lacy rash was now solid red and covered the majority of the front of my upper arm.  Very painful. and swollen, tight.  Also hot to the touch.  I treated it with Motrin.  The next morning there had been no significant change.  By the afternoon (this is now day 3), area had begun to have a burning, itch sensation.  That evening  I marked the area with a pen and took Benadryl.  Today is day 4 and it is still painful, swollen and itchy.  Area  has not changed in size but is less red.