chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RIGHT EYE HURTING; SHAKINESS; BLURRY EYE; NAUSEA WITHOUT VOMITING; LOW GRADE FEVER OF 101.4; MUSCLE ACHES; FATIGUE; CHILLS; This spontaneous case was reported by a health care professional and describes the occurrence of EYE PAIN (RIGHT EYE HURTING), TREMOR (SHAKINESS), VISION BLURRED (BLURRY EYE), NAUSEA (NAUSEA WITHOUT VOMITING) and PYREXIA (LOW GRADE FEVER OF 101.4) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced EYE PAIN (RIGHT EYE HURTING), TREMOR (SHAKINESS), VISION BLURRED (BLURRY EYE), NAUSEA (NAUSEA WITHOUT VOMITING), PYREXIA (LOW GRADE FEVER OF 101.4), MYALGIA (MUSCLE ACHES), FATIGUE (FATIGUE) and CHILLS (CHILLS). At the time of the report, EYE PAIN (RIGHT EYE HURTING), TREMOR (SHAKINESS), VISION BLURRED (BLURRY EYE), NAUSEA (NAUSEA WITHOUT VOMITING), PYREXIA (LOW GRADE FEVER OF 101.4), MYALGIA (MUSCLE ACHES), FATIGUE (FATIGUE) and CHILLS (CHILLS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   patient used unspecified eye drops as treatment medication
Started having a headache, congestion and a cough. Took Home Antigen COVID test and it was positive. Called Doctor but decided not to get a prescription and just rested. Took another COVID-19 test on 01/25/2023 and it was negative.
Information has been received from an administrator referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose and route unknown; lot # M001814 with expiration date 15-OCT-2018, lot # L042835 with expiration date 19-AUG-2018). The lot # M001814 of the vaccine was exposed to temperature excursion of 46.58 Fahrenheit degree (F) for 26 hours 30 minutes, and lot # L042835 was exposed to 50.45 F for 32 hours 45 minutes. Data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient became fussy on 10/26/19. In the AM of 10/27/19, she vomited, then had blood in stool. seen in our urgent care clinic. referred by ambulance to Hospital. Diagnosed with an intussusception . this was reduced. observed and discharged home.
Two hours after vaccination, I went into heart bradycardia.  My HR went down to 38.  I felt as if I was going to pass out.  My husband helped to keep me safe and alert.
I had a sore arm for the first 48 hours. During the 2nd day, my nerve issue returned in my right arm and I have been dealing with nerve pain, tingling, numbness, difficulty using my fingers. The symptoms are now in both hands and feet (it had only been in my right arm, and only occasionally prior to the vaccine) so I am back on heavy meds and obviously not taking the 2nd dose.
Over the course of first 48 hours, had muscle aches, 101 fever, headache, fatigue, and tinnitus. I continue to have tinnitus 10 days later.
Initial report received on 09 Dec 2009: This subject was enrolled in a study. The subject received the first dose of 15mcg A/H1N1 with 50% MF59 on 15 Sep 2009. The subject received the second dose on 06 Oct 2009. The subject's medical history included allergy to penicillin. On 16 Oct 2009, the subject was seen in the emergency room with right sided facial paralysis. The subject was diagnosed with Bell's palsy. The subject received treatment with Acyclovir and prednisone. The paralysis gradually resolved and the subject had completely recovered by 18 Nov 2009. The Bell's palsy was not considered serious, however Novartis considered the event to be medically significant. The investigator did suspect a relationship between the event and the study vaccine. Follow-up received on 14 Dec 2009: The patient did not drop out of the study due to the event. Follow-up received on 25 Jan 2010: The subject experienced facial droop with weakness of the right face (moderate) and headache. On 16 Oct 2009, the subject underwent an electrocardiogram (EKG) which was normal and a computerised tomogram (CT) of the head to evaluate the left sided facial droop. The appearance of the brain was normal with no ischemic areas or gross temporal bone lesions. Mild sinus changes were noted. The subject was discharged from hospital in good condition. The subject was treated Acyclovir, prednisone and 'Lacri-lube ophthalmic ointment'. Follow up literature report received on 17 Nov 2014: The reported event of "Bell's palsy" was cited in an article.
The patient experienced elevated blood pressure (150/98) lasting several days and multiple and ongoing occurrences of heartbeat irregularity (PVC's) per day.
I provided the vaccine to the patient.  She was very anxious preceding the vaccine per my observation of her behavior, her own report and her grandmother's comments.  She said that she tolerated the first vaccine well except for a "dry throat" that was relieved with sips of liquid.  Fourteen minutes after the vaccine her grandmother reported that the patient was distressed.  I observed that the patient was conscious, able to talk, and panting.  She didn't appear pale or sweaty.  I offered to call an ambulance and the patient and grandmother agreed.  The patient complained of swelling and difficulty breathing.  She did not wheeze or complain of dizziness or nausea.  The patient's grandmother refused an EpiPen injection.  The ambulance arrived and the patient was taken to the ER.
Hives over trunk, arms, neck. Took BENADRYL over the counter.
Rec'd MMRV and KINRIX on 2/21 at 4 y.o. WCC. Seen 2/23 for (L) outer arm swollen at MMRV site. Dx with cellulitis on cephalexin, afebrile no other c/o.
Hives on legs, narrowing of throat, inability to walk, swelling of joints and limbs.
pt recv vax 31JAN96 & & 6JAN97 pt devel active chickenpox;
Baby found not breathing at baby-sitter's. Resuscitation efforts to no avail.
This spontaneous report as received from a nurse refers to a 11 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 15-SEP-2017, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N019923, expiry date: 28-APR-2019) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: US-009507513-1709USA007012: US-009507513-1709USA007011: US-009507513-1709USA007014.
Patient accompanied by mother who provided history. COVID vaccine yesterday  normal day yesterday, felt fine, slept fine last night, ate typically this am about 30 minutes after eating  he  started told his mom he was  hot and  dizzy feeling , his head hurt, mom noticed he was very pale, then" eyes rolled back" while he was sitting down, and he flopped toward  mom, shaky rigid arms for a couple of beats, brief time -a second was not  responsive, then he came to and was  scared, asked questions, was not sure what happened, felt very hot stripped down, mom gave  water with electrolytes, seemed a bit tired though only for a brief time and has been fine since  no fever or achiness, no headache now, no loss of bowel or bladder control during episode  .
I had it twice before the vaccine and twice afterward/Suspected Vaccination Failure; I had it twice before the vaccine and twice afterward; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles twice before the shingles vaccination).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had it twice before the vaccine and twice afterward/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had it twice before the vaccine and twice afterward). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the shingles four times. The patient had shingles twice afterward the shingles vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Patient had a fever of 100+ beginning on day of vaccination and continuing for 3 days following vaccination. She also experienced an inability to move in both legs (injections only given in one). She was unable to stand up, walk, take herself to bathroom, etc for the 3 days following injections. Adverse events reported to Dr. office. Recently we moved and found the information was never recorded in the patient record - also assuming it was not reported which is concerning.
Some soreness on the left arm day of and the next day after the shot. 7/16 some muscle aches and really fatigued around 3:00p.m. On 7/17 fatigued, hand tremors and joint pain.
reported hoarseness in the voice; itching and burning sensation around the throat; shortness of breath; This is a spontaneous report from a contactable nurse. This 42-year-old female nurse (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0142), via an unspecified route of administration on 05Jan2021 17:00 at single dose in the right arm for COVID-19 immunisation. The patient had anaplasias to penicillin and COVID. The concomitant medications was none. The patient experienced hoarseness in the voice on 07Jan2021, itching and burning sensation around the throat in Jan2021. She had shortness of breath in Jan2021 related to COVID-19 infection. She has  had COVID already so she isn't worried about that but wants to know if it is related to the vaccine or not, if this is something she needs to be aware of. The event started and gradually was getting worse. She had her inhaler from when she had COVID. The patient clarified she has also had some shortness of breath but this has been going on since having COVID. She did try the inhaler for the hoarseness and shortness of breath she had. She has been interment shortness of breath since having COVID and she is being tested for lung damage. The inhaler didn't change the hoarseness or shortness of breath. The product used was salbutamol (ALBUTEROL), Lot: PK0358, Expiry: Jun2022, NDC: 0093317431. She has had no reactions to vaccines previously, she had no vaccines on the day of or in the previous 4 weeks. She has not been to the doctor or ER related to the event. The outcome of the event hoarseness in the voice was not recovered. The outcome of other events was unknown.
Dose Number 3: 13Sep2021; recovering from hip surgery 07Feb2022; 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Dust" (unspecified if ongoing), notes: Known allergies: Dust. Concomitant medication(s) included: ATORVASTATIN; OXYBUTYNIN; VOLTAREN [DICLOFENAC], start date: 08Feb2022, stop date: 08Feb2022; ACID CONTROLLER. Past drug history included: Percocet, reaction(s): "Known allergies: percocet", notes: Known allergies: percocet; Poison ivy, reaction(s): "Known allergies: Poison Ivy", notes: Known allergies: Poison Ivy. Vaccination history included: BNT162b2 (vaccine_dose_number_unknown=Fals, e}, {vaccine_brand=Pfizer / BioNTech,, vaccine_brand_unknown=False,, vaccine_administration_date=09Mar, 2021, vaccine_lot_unknown=True,, vaccine_lot_unknown_reason=Not, available/provided to reporter at the, time of report completion,, vaccine_dose_number=2,), administration date: 09Mar2021, for Covid-19 immunization; BNT162b2 (vaccine_dose_number_unknown=Fals, e}, {vaccine_brand=Pfizer / BioNTech,, vaccine_brand_unknown=False,, vaccine_administration_date=17Feb, 2021, vaccine_lot_unknown=True,, vaccine_lot_unknown_reason=Not, available/provided to reporter at the, time of report completion,, vaccine_dose_number=1,, vaccine_dose_number_unknown=Fals, e}]), administration date: 17Feb2021, for Covid-19 immunization. The following information was reported: HIP SURGERY (medically significant) with onset 07Feb2022, outcome "recovering", described as "recovering from hip surgery 07Feb2022"; OFF LABEL USE (non-serious), outcome "unknown", described as "Dose Number 3: 13Sep2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative twice/Tested negative again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vomit no stop cold chills stomach pain cramping , diarrhea.headache .
Large local reaction on L anterolateral thigh visit on 7/24/02 showed 4 x 7cm induration surrounded by 10x14cm erythema. Tx-Benadryl 25mg Q 6, cool compress, Cortisone.
LEFT Greater saphenous vein below the knee with occlusive thrombus of greater than 5 cm
Flu-like symptoms within one-two hrs - dizziness, nausea, fever, flush - lasting up to time of this form completion. Reaction at injection site up to 4 days after, swollen, hotness, reddened area.
Headache, Myalgia, Arthralgia, chills, inj site pain Narrative:
Patient reported having lower back pain, high blood pressure, chest pressure, weakness, and trembling 10 minutes after receiving vaccine. I checked patient's blood pressure and it was elevated at 183/103 mmHG. An ambulance was contacted for patient. She reports taking her metformin in the morning but did not take her blood pressure medication. Her son brought her enalapril to the pharmacy and she took it as well as a hydroxyzine because she did not know if her anxiety was causing it. She reports to having similar episodes in the past.
Information has been received from a health professional concerning a 5 year old Hispanic male, with no known allergies, who on 06 Jun 2001 was vaccinated with a first dose in the right deltoid of Varivax (Lot # 635453/0756K). Subsequently the patient experienced a mild case of breakthrough chickenpox. It was reported that the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from a health professional indicated that on 20 Apr 2006 the patient had general lesions on his body since the morning. The patient was diagnosed with chickenpox. It was reported that the patient recovered on 27 Apr 2006. The patient's chickenpox was considered to be an other important medical event by the reporter. Additional information is not expected. Two of the patient's brothers experienced varicella following vaccination with Variavax (WAES # 0605USA00668 and 0605USA00678).
something is stuck in chest; odd acid reflux burning; Very painful arm; sharp pains in chest that made me catch my breath; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 54-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6206, Expiration date was not reported), via an unspecified route of administration in arm left on 09Mar2021 at 08:45 AM (at the age of 54-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history included known allergy: Melons. Past drug event included Tylenol w/codeine and experienced allergies. The patient's concomitant medications in two weeks included generic fexofenadine, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), both were taken for an unspecified indication. It was reported that, the patient was not pregnant at time of vaccination. No other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. On 09Mar2021 at 19:30, the patient experienced very painful arm. The evening of the vaccine she felt sharp pains in chest that made her catch her breath. Next morning, on 10Mar2021, after breakfast she started feeling what she described as an odd acid reflux burning but not like she had ever felt before. Also feeling like something was stuck in chest. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment was not received for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Friday afternoon I had the vaccination, 04/09/2021, Saturday morning I felt bad all day, feverish, low grade fever, I was just worn out. Sunday morning felt better. Sunday night I wound up with a fever again. Monday I was fine. I have been tired lately, several months later after the vaccine. I sleep with the CPAP so I have been getting good sleep. Around in May yellow stool. I went to the doctor and had an ultra sound, gall bladder checked out, blood work was all normal. Since May I occasionally have the yellow stool, but not regularly. It's only a day or 2 at a time, intermittent. Other than that, I am just tired all the time.
p/3/1/99 lt middle finger joints extremely swollen & disfigured; all fingers on both hands extremely swollen (outer joints) & disfigure x/ring fingers; also rt shoulder & ankle pain; lt ankle pain;
Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA298672, 2018SA298673, 2018SA298674, 2018SA298675, 2018SA298676, 2018SA298677, 2018SA298678, and 2018SA298679 (same reporter). This case involves a 49-Years old female patient who was inadvertently administered with a dose of 0.5 mL FLUZONE HIGH DOSE (frequency once) lot UJ039AA, expiry date 15-May-2019 via unknown route in unknown site on 25-Oct-2018. The patient's medical history and concomitant medications were not reported. It is an actual medication error case due to inappropriate age at vaccine administration and overdose. It was reported that employees were inadvertently administered FLUZONE HIGH DOSE to the employees aged 32-62 years old. At the time of report, none of the patients report any reaction. 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. List of documents held by sender: none.
I finished a hot bath as I do every evening.  When getting into bed, a chill started in my shoulder blades and quickly swept across my back and down my front.  I felt freezing cold and crawled into bed.  Almost immediately the muscles running from my head to my body seized shut.  The muscles were pulled taught under my skin and my throat narrowed.  I could barely get a single word out as I struggled for breath.  I asked my to get me warm.  She was frantic and wanted to call an ambulance.  I couldn't guide her thru a tracheotomy and if it worsened I wouldn't live to see an ambulance.  I felt if I stayed calm and could get warm it would pass.  In about five minutes the muscles unfroze and I could breath freely again.
This case was reported by a pharmacist via sales rep and described the occurrence of generalized rash in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. It was not reported if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced diffuse full-body rash after receiving SHINGRIX. Rash occurred within a few days after vaccination. No further details were known.
Flulike symptoms,  Chills for 4 hours, now hot  Aching joints Dizzy Stomachache  Muscle aches Blurred vision
Starting 10/13 developed right groin pain which resolved, then achy pain right anterolateral thigh then right hip flexor weakness then partial right hip extensor weakness causing difficulty climbing and descending stairs and dressing. Need to lift leg with hand to get into car or to lift foot 12 inches
Pt developed a sore red rash around administration site that was warm to the touch.  Pt came back to pharmacy to show pharmist his arm on 9/24/2014.  Pt was advised to take Benadryl and monitor for any signs that it is getting worse such as fever, rash spreading, or difficulty breathing.
60-70hr p/vax pt devel temp to 103, vomited several times;nl CBC;saw MD;vomited x 1, went limp, cardiac arrest;
Information has been received from a licensed practical nurse concerning a 23 year old female patient with drug allergy to BETADINE, allergy to shell fish and no pertinent medical history who on 28-FEB-2011, was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly (lot number 666597/0768Z, Exp: October 2012). On 06-MAY-2011, the patient was vaccinated with the second dose of GARDASIL 0.5 ml, intramuscularly (lot number 667878/0180AA, Exp: March 2013). Concomitant therapy included LOESTRIN 24 FE and cyanocobalamin. In 2011, after administration of the first and second dose of GARDASIL, the patient experienced pain at injection site. On approximately 06-MAY-2011, after second dose of GARDASIL, the patient had been experiencing headaches, swollen neck glands, joint and back pain after second dose of GARDASIL. The patient did not receive any treatment for the event and no laboratories were performed. The patient sought medical attention via a telephone call. At the time of the report the patient was recovering. Additional information has been requested.
Patient received vaccine on 2/25/21.  Reported side effects started on 3/5/21- generalized hives or itching and swelling of lips, face and throat.