chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bored the next day; a little less perky; This spontaneous case was reported by a consumer and describes the occurrence of BOREDOM and FEELING ABNORMAL in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Arthritis flare up. Previously administered products included for Product used for unknown indication of Flu in 2020. Past adverse reactions to the above products included Swollen joints with Flu. Concurrent medical conditions included Arthritis.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced BOREDOM and FEELING ABNORMAL. At the time of the report, BOREDOM and FEELING ABNORMAL outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  It was reported that patient has had received pneumonia shot in 2020 and had swollen joints. She stated after receiving the Moderna COVID-19 vaccination, she reported that it wasn't bad at all and she didn't have much going on after the injection.   Reporter did not allow further contact.
An hour later, sweating profusely and started blacking out. Visual impairment-was seeing red moving spots and could not see around them. Pain in neck on both sides and very SOB. Serious diarrhea immediately that was white and smelled like metal. At least an hour to subside.
On the ipsilateral side as the vaccine (left), I noticed lymphadenopathy in the supraclavicular area.  I had one swollen lymph node.  I noticed this was plausibly a side effect  from the CDC website.  On Monday, the size of the lymph node decreased by about half.  Same for Monday and Tuesday.  On Wednesday, the lymph node is no longer palpable.
Throwing up all night.  Temperature of 99.0, rash all over body.  Treatment Benadryl.
on 1/7/2022 an  incorrect dilution of Pfizer covid-19 vaccine lot # FJ87757 expiration date: 01/26/22. Vial was diluted with 1.3 ml of sodium chloride and administered to three patients at 0.3ml . All other remaining vaccine was  discarded. Call was placed to Help desk and  Voice message was left on after hours phone number. Pt was contacted and instructed may have increase in side effects. Pt was given after hours number. Pt verbalized understanding   Resolution : CPM and DO were notified as soon as the mistake was noticed. Pt was contacted and instructed may have increase in side effects. Pt was given after hours number. Pt verbalized understanding
I had some normal side effects at first like headache and fatigue and then about a week later, I got the 9 positional vertigo. If I was sitting down, upon standing up the room would start spinning or if I was laying down and sat up into the sitting position, I would literally fall over and back into bed because I was so dizzy.
soreness at the injection site after 3 hours of injection and resolved after 10 hours; This is a spontaneous report from a non-contactable consumer (patient). A 38-years-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration, administered in right arm on 04Feb2021 (at the age of 38-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Facility type vaccine was Workplace clinic. Reportedly, patient did not had covid prior vaccination and was not tested for covid post vaccination. On 04Feb2021, the patient experienced soreness at the injection site after 3 hours of injection and resolved after 10 hours. No treatment was received for adverse event. The outcome of event was recovered on unspecified date of Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
booster; chronic upper back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 15Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 12Feb2021, for Covid-19 immunization, reaction(s): "covid-19"; Bnt162b2 (Dose 2), administration date: 26Feb2021, for Covid-19 immunization, reaction(s): "covid-19". The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021, outcome "unknown", described as "booster"; BACK PAIN (non-serious) with onset Dec2021, outcome "not recovered", described as "chronic upper back pain".  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a nurse practitioner refers to a group of unspecified patients. The patients were vaccinated with VAQTA (date, route and lot number unknown). No other co-suspects were reported. No concomitant medications were reported. On unknown dates the patients received vaccin doses that were exposed to temperatures above 46 F for 45 minutes, with the highest temperature of 78 for 15 minutes. No adverse effect reported. No treatment information was reported. Information about GARDASIL, PNEUMOVAX23, PEDVAXHIB and RECOMBIVAX HB that were exposed to temperatures above 46 F for 45 minutes, with the highest temperature of 78 F for 15 minutes is also reported. This is information is processed in the linked cases: 1210USA007111, 1211USA001302, 1211USA001296 and 1211USA001298. Additional information has been requested.
RESIDENT INDICATED THIS WAS HIS 1ST COVID DOSE, WAS NOT IN PASIIS PRIOR. UPON ENTERING WHAT WAS THOUGHT TO BE THE 1ST DOSE, THEIR APPEARED A PREVIOUS 1ST DOSE OF PFIZER BY ANOTHER PROVIDER
Initial report received from a consumer (the patient) on 23 December 2013: A 72-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HD, (batch number, dose number, route and site of administration not reported) on 25 September 2013. The patient experienced body wide itching two weeks later, on an unspecified date that comes and goes and rash was continuing. Laboratory investigations and corrective treatments were not reported. At the time of this report, the patient had not recovered. Documents held by sender: none. Follow up information was received on 17 January 2014: The patient had received FLUZONE HD vaccine. The patient never had any reaction with flu vaccine. It was reported that the patient experienced itching. The patient received treatment with clotrimazole, betamethasone and dipropionate topical cream for her rash. The patient agreed to send the available information.
From initial information received on 01/20/04, from a health care professional regarding an adverse event occurring in the USA, it was reported that a one year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1145AA, administered in the left thigh as well as a dose of MMR, lot number 0512N, a dose of Varicella, lot number 0579N and a dose of Prevnar, lot number 491178, on 12/23/03. The routes and sites of administration were not reported. On week later, the patient developed eight small red dots located on her head, torso and genitals. Reportedly, the spots may have been hives. The patient's recovery status was not reported. From additional information received on 05/18/04 from the initial reporter, a correction was made to the patient's initials. It was reported that the patient had no illnesses at the time of vaccination and had no relevant past medical history. She required no treatment or evaluation following the adverse event and has had no reoccurrence of the symptoms.
pt recv vax & 2 days p/vax pt exp diarrhea & 1wk post vax pt devel a fever;
Pt recv vax on 1/28/99; on 2/1/99 pt exp rash, bumps on legs, fever (100.8); tx=Zithromax
Weakness, chills, h/a last 4 day cont w/being tired x 7 days;
Within 5 minutes of vaccine being administered I experienced Dizziness and Headache.  Additional symptoms experienced later in the day/overnight included muscle pain, fatigue, headache, chills, nausea, slight fever and slight swelling around /under my eyes
03/13/2021: Presented with elevated blood sugar after having bilateral knee cortisone injections yesterday. Insulin regimen adjusted and patient discharged within 3 days.
Varicella-like rash on trunk, scalp and extremities about 8 days after Varivax and MMR vaccines.
Patient was talking to this nurse after receiving vaccines and suddenly stopped talking.  She became rigid, flexing right arm and leg and pulling right hand into a fist.  Called for help to the room.  Patient became limp and unresponsive, color pale.  Provider assessed patient.  BP 86/52, Pulse 60-65, Oxygen 98% room air.  Patient became responsive and able to answer questions, cool cloth applied to head.  Continued to complain of tingling in bilateral arms.  Patient's mother arrive (verbal consent from mother prior to visit).  Ambulance service called for transfer to ER.  Patient's condition improved while waiting for ambulance.  BP 90/60.  It was determined patient could be taken by family car to ER.  Assisted to car via wheelchair.  Mother escorting to ER.  Report called to ER.
Excessive irritability, crying constantly (unusual for child) "appears to be in pain" injection sites look normal, given Tylenol.
Severe headache that has been ongoing since  5/23/2021.  Also, Covid- like symptoms such as sore throat, coughing, chills, congestion, anorexia, fatigue, shortness of breath, and general malaise.  Symptoms are significant at day 5 after shot.
My initial symptoms were very minor and occurred the day after I received the vaccine: 99.5 degree fever and very mild headache. But several days later, both legs felt strangely weak from the calves to the feet. I also experienced occasional tingly feelings, pain, and often numbness. It was subtle at first but increased in intensity until April 21. I began to fear Guillain Barre syndrome. I scheduled a doctor's appointment for April 22, but the doctor's office cancelled and told me to go to the ER. At the ER bloodwork was done, which was normal. I was told to follow up with a neurologist if needed. It is now May 2 and my symptoms have slowly improved. It was frightening to have the symptoms for about a month. I was prepared to possibly feel unwell for several days, but expected neither my symptoms nor their duration.
2 day later L -arm -deltoid generalized local reaction 9 cm x 6 cm - erythema - induration.
Rash starting on torso and spreading to extremities.  No blistering.  Use hydrocortisone BID to body, QD to face.  Treatment for rubella / viral exanthem.
child was administered an expired Pentacel vaccine, no adverse event reported; Initial information received on 14-May-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves child patient who was vaccinated with expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error due to expired vaccine used.  It was reported that a child that was administered an expired Pentacel vaccine.  It was not reported if the patient experienced any adverse event following vaccination.  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 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.  Information on the batch number was requested.  List of documents held by sender: none.
On 1/20/21 I had bad swollen nodes on my right side of my neck and lower scalp. Had doc at work monitoring, thought it was random MRSA or staph and was hot packing it. On 1/24/21 developed bumps on right side of neck and chin (couldn?t easily asses on own) and thought it was acne. Doc looked on Tuesday and diagnosed with shingles. Little one sided spots of itchy, burny, needle feeling and fatigue and lack of appetite and tiny blisters. Now on antivirals
This spontaneous report as received from a healthcare worker, office manager, refers to an unknown umber of patients of unknown age and gender. Concomitant medication and pertinent medical history were not provided. On unspecified dates the unknown number of patients were vaccinated with doses of GARDASIL (lot#, dose, route and frequency were not provided), which were exposed to supported temperatures out of range. No adverse effect has been observed or reported. This is one of several reports received from the same source. Additional information has been requested.
expired dose administered; Vaccine expired on 29 Apr 2022 and vial was stored in the refrigerator on 17 May 2022 (expired vaccine stored and then administered); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered) and PRODUCT STORAGE ERROR (Vaccine expired on 29 Apr 2022 and vial was stored in the refrigerator on 17 May 2022 (expired vaccine stored and then administered)) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered) and PRODUCT STORAGE ERROR (Vaccine expired on 29 Apr 2022 and vial was stored in the refrigerator on 17 May 2022 (expired vaccine stored and then administered)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered) and PRODUCT STORAGE ERROR (Vaccine expired on 29 Apr 2022 and vial was stored in the refrigerator on 17 May 2022 (expired vaccine stored and then administered)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment  medications were reported. It was reported that the vial was initially stored in the refrigerator at the same date that the dose was administered. The vial did not undergo any temperature excursions.
Initial information received on 07-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional (Medical assistant). This case involves an unknown age patient who received a dose of expired vaccine PENTACEL. On an unknown date, the patient received a dose of suspect PENTACEL Lot number, expiry date, dose, route and site of administration was not reported. It was a case of actual medication error due to expired vaccine used. 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 holder's 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. Documents held by sender: none.
Acute inflammatory demyelinating polyneuropathy that developed ten days following first dose of Moderna vaccination.   Patient developed progressive weakness/numbness/tingling and presented to outside hospital 6/10;  weakness progressed to near immobility with associated respiratory distress, resulting in intubation 6/19.  EMG consistent with AIDP.  S/p 5 days of IVIG without improvement; now started on PLEX s/p 2 days.  LP with protein, which can also be explained by AIDP.   Remains intubated and hospitalized presently.
I received my vaccine around 12:45pm. They had me go to waiting room and wait for 10 mins. I sat down and was waiting for a few minutes when I started to get dizzy. I looked up and told the lady checking people in ?hey I?m getting really dizzy can I lay down? she said yes come in the room. When I stood up my heart started beating really fast. I sat on the table and my chest started feeling tight and heavy. There were 2 ladies in the room at this point so I asked one of them if they had an epipen on hand just in case. My throat wasn?t swelling but it was getting harder to breath from the tightness in my chest. She said they didn?t have an epipen and would have to call emergency services if I needed one. I told her I didn?t know what was going on, that I didn?t need one yet but she should probably call emergency services if they can?t do anything to help me. (ER is right across the street) my symptoms went away shortly after they called. But came on a couple more times but much milder over the next 30 minutes or so. The EMT gave me Benadryl and the ER ran some tests.
3 minutes after given influenza vaccine, noted to be pale by nurse. C/o lower chest/abdominal discomfort. I was called to room. Child was pale, sweaty, c/o being tired and was saying "I feel funny". HR 40 and irregular, got equipment to get BP and O2 sat, when he vomited a large amount, then improved O2 sat 98%. HR 80-82, BP 88/60, monitored 10-15 minutes. Remained stable and states felt so went home.
Information has been received from a registered nurse concerning now a 14 month old female who on 06/11/2001 was vaccinated with a dose of a varicella vaccine. On 08/08/2001, it was reported that the pt "now has chicken pox." The pt sought unspecified medical attention. Additional info has been requested.
This spontaneous report as received from a physician via a company representative refers to a 12 year old female patient. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot#, dose, route not reported). Concomitant medications were not provided. The physician reported that she read a report, possibly online, about the patient who had a seizure on an unknown date after administration of GARDASIL and died on 31-JUL-2014. The cause of death was unspecified. The patient had sought unspecified medical attention. Outcome of seizure was unknown. Causality was not provided. Upon internal review, seizure was determined to be medically significant. Additional information is not expected because the reporter did not want to be contacted.
Day 1: 6:00 PM - arm soreness began, had great pain when reaching overhead.  Subsided by noon 2/12/2021 8-8:30 PM - chills began, no fever. Day 2: 7:45 AM - woke with moderate headache; not a migraine. Treated with twice throughout the day with 1-500 mg  ES Tylenol; 2-200 mg ibuprofen.  Was gone at approx. 5 PM Day 3: 10:00 PM - Discovered rash under breast area, all around lower abdominal area, into upper thighs. Did not itch, but once clothing was removed, the swelling began and my clothing became an irritant. Thinking it was a food allergy, I treated with 2-25 mg Benedryl.  Continued into Day 4. Day 4:  AM/PM - still very red and swollen causing discomfort, no itching or burning. still treating off and on with Benedryl and added Cortisone Ointment. The rash has spread but not near as bright red or mass like, found on back of thighs, down inside of arms, behind knees. Also took Colloidal Oatmeal bath, with minimal affect.
patient with c/o increased HR and scratchy throat, BP 113/78 HR 130 Pulse Ox 95% on RA, patient response called, patient transported to Emergency Department and received Famotidene 20mg IV, Diphenhydramine 50mg IV, Lorazepam 1mg Oral, Ketoralac 15mg IV, one liter normal saline. Observed and discharged home.
I noticed a rash on my torso on Monday night - 4/12/21.  It reminded me of chicken pox.  It became increasingly itchy.  On Tuesday it was more pronounced (redder) and itchier.  I had difficulty sleeping on Tuesday 4/13/21 evening and the itching and redness became even more intense.  I called my health care provider on 4/14/21  and was told to take Benadryl and/or Claritin and apply ice pack to itchy patches and avoid hot water showers. I used an ice pack throughout the day on Wednesday.  On Wednesday evening I took 1 Benadryl at 9 p.m. and applied an ice pack throughout the night to sleep.   I used the ice pack  throughout the day on Thursday and took 1 Benadryl at 9 p.m. on Thursday 4/15/21.  The itchiness, redness and spots were decreasing throughout the day on Thursday.  I used an ice pack overnight for relief to sleep.  When I woke on Friday 4/16/21 the rash was about 95% gone and the itchiness greatly reduced.  I was comfortable, had no spots and had normal energy starting Saturday 4/17/21.  The rash never got hot to the touch, just very itchy and uncomfortable.
AFTER PATIENT TOOK THE VACCINE PATIENT FELT FAINT/PROFUSE SWEATING/DIZZY./AND BECAME PALE. APPLIED COLD PACK TO BACK OF NECK AND CHEST AND ONCE PT STARTED FEELING BETTER SHE HAD A SIP OF WATER AND WAS GOOD TO GO
Feeling Nervous and anxiety. Didn't eat before coming. Seen by an onsite EMS. Discharged home at 12:00 p.m.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of UNK dosage form. At the time of the report, HEADACHE (headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications was not provided.
Fever, headache, tender skin all over. Bilateral lower tingling extremity weakness and loss of sensation starting in feet progress to legs and stomach.  Vesicular rash on buttock( right) loss of mobility