chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cannot drive, not feeling safe taking care of my child, have a hard time reading and working due to the dizziness; SEVERE VERTIGO that causes nausea and throw up on the first and second day, followed by constant dizziness throughout the day and night that does not cease. Suspecting nerve damage; SEVERE VERTIGO that causes nausea and throw up on the first and second day, followed by constant dizziness throughout the day and night that does not cease. Suspecting nerve damage; SEVERE VERTIGO that causes nausea and throw up on the first and second day, followed by constant dizziness throughout the day and night that does not cease. Suspecting nerve damage; SEVERE VERTIGO that causes nausea and throw up on the first and second day, followed by constant dizziness throughout the day and night that does not cease. Suspecting nerve damage; This is a spontaneous report from a contactable consumer (patient). This 38- year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: ER8733), via an unspecified route of administration, on 01Apr2021 at 02:00 pm (at the age of 38-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a Public Health Clinic facility and anatomically located on the left arm.  Allergies to medications: CIPRO. The medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01APR2021 01:00, she experienced severe vertigo that causes nausea and throw up on the first and second day, followed by constant dizziness throughout the day and night that does not cease. Suspecting nerve damage. Cannot drive, not feeling safe taking care of my child, have a hard time reading and working due to the dizziness. Treatment received for the adverse event: IV, Benadryl and other medication. The clinical outcome of the events was not recovered. On 05Apr2021, the patient was tested for COVID-19 via Nasal Swab since having the vaccine, with a negative result.  No follow-up attempts are possible. No further information is expected.
Large cold sore/lesion on top left lip - open - treated at home with abreva/hydrogen peroxide. Pain from top of lip to left eye, pain bottom lip, gland swollen under left side of mouth. Lips became very dry. Has not totally gone away, still treating at home  no pain from lip to eye or mouth anymore gland not swollen.  However intense pain lasted four days.
Nausea, vomiting, diarrhea. Unable to hold down any fluids or food, including water, Gatorade, juice.
Breakthrough case of COVID after 2 doses of vaccine; Breakthrough case of COVID after 2 doses of vaccine; Very tired; woke up for just  one morning sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 40 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "Breakthrough case of COVID after 2 doses of vaccine"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Very tired"; HYPERHIDROSIS (non-serious) with onset 2021, outcome "recovered" (2021), described as "woke up for just  one morning sweating".  Clinical information: Patient received a report of a Breakthrough case of COVID after 2 doses of vaccine. Female, approximately 40 years of age. It had been 6 months since their second dose. No booster yet, mild symptoms. Very tired, woke up for just one morning sweating. Only felt symptoms for a few days, other than that was okay.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Swelling of injection site enlareging to an area of 4" x 8"over several days becomeing cellulitis.  Headache for four days.  Antibiotics began on 4th day with inprovement after four more days.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date during 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On an unspecified date during 2016, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. 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. The outcome of the events is unknown. Additional information has been requested.
Breakthrough COVID infection in fully vaccinated patient. Positive date 09/30/2021.
Patient has exp difficulty breathing, rapid heart beats, dizziness and weakness. Also had a fever of 99.0 on 10/27/20
1st dose of Moderna vaccine administered at 1608 in the right deltoid. At 1615 during the waiting period the patient reported mild itching and reports this has happened with the Flu vaccine. 1620 itching became progressively worse. 1624 Benadryl 50mg IM was administered into right gluteus. 1634 pt reports sx are relieved. Educated on follow up and CDC recommendation not to take the vaccine nor the 2nd dose again. Educated on emergency protocol and sx management. Pt was accompanied by a friend who says she will drive and take patient home.
Patient stated she had  brief tingling in lips and then a small lump in throat which she has with allergic rhinitis which she has been currently experiencing Narrative:
The shot stung a lot when given.  In about 30 min. it was still hurting to the touch.  Within 24 hours it was hot to the touch and hurt only if I pushed on it.  Today (10/07/2014) it was hot and red.  I went to the pharmacy to show the pharmacist and she told me to report it.  She said to go to my doctor if it wasn't better by tomorrow.  I marked a black line to show me the size today and so that I can see if it gets bigger.
Information has been received from a physician concerning a female with a history of seizures who on an unspecified date was vaccinated with the second dose of GARDASIL. Subsequently, "a couple months later", the patient experienced a seizure. On an unspecified date, the patient recovered from seizure. The patient sought unspecified medical attention. Seizure was considered to be immediately life-threatening. Additional information has been requested.  5/29/09 Neurology DOS 7/10/08 to 9/25/08. Includes copy of ER medical records of 6/19/08 previously abstracted. FINAL DIAGNOSIS: Complex Partial Seizures Post vaccination awoke with nosebleed. Later found thrashing in bed having seizure, head back and to the left, eyes rolled back, left arm banging bacl and forth and drooling. Seen at local hospital ER then transferred to higher level of care. Another event occured consisting of staring and drooling at that facility. Upon discharge had two more events and returned again to the ER. The evening of 7/9/08 at home and on 7/10/08 during EEG she had an events consisting of chewing, mouthing movements, staring, and difficulty speaking.   5/29/09 Received ER medical records of 6/19/08. FINAL DX: new onset seizure Records reveal patient experienced bloody nose, left sided shaking spell, eyes rolled back, drooling, dazed appearance followed by postictal state.  Had been seen in outlying hospital & transferred to higher level of care.  Phone consult w/peds neuro suggested benign focal epilepsy.  Recommended meds which family declined.  D/C to home w/outpatient neuro consult.  Neuro addendum states parent reported additional staring/drooling on way home, again offered meds & again parents declined.   6/8/09 Received ER medical records of 6/19/2008. FINAL DX: seizure Records reveal patient experienced nosebleed, went to bed. Awakened parents later w/noise & found to be shaking, drooling for approx 1 min.  Then confused, garbled speech w/no memory of event.  Transferred to higher level of care.  6/8/09 Received ER medical records of 2/6/09. FINAL DX: exudative pharyngitis; dehydration Records reveal ptient experienced fever & sore throat x 2 days & vomiting x 1 day.
The day of the vaccine I experienced swollen lymph nodes under the left underarm. I developed a cold, and began to become lethargic and sick for one week. Since then, I've been experiencing chronic joint and muscle aches in my arms, shoulders, hands, lower back, neck, legs and feet. I've tried icing these areas and taking joint supplements, but the pain and discomfort will not abate. I've never experienced this chronic pain until after I began to take the Gardasil vaccine.
Pt was given his first dose of pfizer today and was observe for 15 mins with no problems, however pt came back with wife and stated he was having blurred vision, ears popping, and felt like he was about to pass out. I told pt and pt wife to go to the nearest er/ urgent care which was across the street. Pt and pt wife verbalized understanding.
NAUSEA, VOMITING, CHILLS STARTED AT 8 AM. EMESIS WAS CLEAR AND WATERY. FELT BETTER AND HAD NO SYMPTOMS BY 8:15 AM.
got dose Sat, was very sore/stiff Sunday, then late Thursday started getting nausea, Sat 3/13 called us to report vomiting now.
generalized tonic clonic sz lasting 3 mins assoc w/fever to 104, rash-sparse maculopapular; pt treated in ER for poss otitis media;
pain in his left shoulder; this pain "seems to be moving around", "in the tendons of the upper muscles", but generally is "on top of the shoulder".; "cannot put his arm in his sleeve" or "put his arm over his head when sleeping".; his HCP suggested that the vaccination provider may have "hit a nerve" during the injection.; he can't sleep at night; This is a spontaneous report received from a contactable consumer (patient). A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Mar2021 (Lot Number: EN6206) as single dose for covid-19 immunisation.  The patient medical history was none. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (LOT:EN6201) on 12Feb2021 in left arm for covid-19 immunisation and had no adverse effect. Prior Vaccinations (within 4 weeks) was none. The patient didn't experience anything from the first dose, yet since the second dose he has been having pain in his left shoulder on 05Mar2021. He specified this pain has being persisting for 10 weeks. He added he cannot extend or use his left arm since it caused agonizing pain in his shoulder joint.  He explained he therefore cannot put his arm in his sleeve or put his arm over his head when sleeping". He mentioned when his arm is down he is fine. He added this pain seemed to be moving around, in the tendons of the upper muscles, but generally was on top of the shoulder. He went to the doctor and he said at 6 weeks in, his HCP suggested that the vaccination provider may have hit a nerve during the injection. Yesterday he had an X-ray taken because it was almost like it was frozen and the doctor looked at it and didn't see anything wrong, yet he said he still has this excruciating pain. He explained he was recommended to apply an over the counter Bio-Freeze, which does do much for the pain. Patient avoids taking pain killers, like Tylenols, because he is afraid of the side effects that may results from these drugs. He can't sleep at night and he can't move his hand to move it under his head or if he puts on a shirt it is agonizing. No emergency Room. Physician Office visit, said the person that injected it must have nicked a nerve. Treatment included Bio-Freeze (Lot: 800621-66 Expiration: JAN2024), he tried to do that but it had little effect. The outcome was not recovered.
92-year-old female with a PMH significant for CAD s/p CABG 2v/PIC, CM (EF 45-50%-10/2021), PAF, systolic/diastolic CHF, HTN, HLD, lymphoma, vaccinated Moderna x2 who presented to the ER for complaints of weakness, dry cough, SOB and decreased appetite for about 2 days reason for which she presented to the ER for further evaluation. In the ER, laboratory data revealing BNP 1026, leukopenia, thrombocytopenia and elevated CRP. CXR read as increased interstitial markings with central pulmonary vascular prominence and small bilateral pleural effusions.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.; No adverse event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.).    This case contains information for the 41th of 100 adult male patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  Nurse reported that an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again. The 100 adult male patients were involved.  Moderna COVID19 vaccine bivalent, dosage given in ml unknown to the HCP.   Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752: case
This is a spontaneous report received from a contactable consumer (patient) via the Pfizer sponsored program. A female patient of an unspecified age received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. She just got her shot at 2 o' clock and she was still bleeding around 5:00 on an unspecified date with outcome of unknown. Information on lot/batch number has been requested.
My daughter was sleeping a lot after the vaccines for the first two days. On the third day she began to very irritable and she had a breakout in hives. Her entire body was red and swollen from head to toe. She was also very itchy behind her ears, in her face at the eyes and nose. She was also eating alot less than usual.
24 hours later had trouble breathing. I have asthma. Had to use nebulizer every 4 hours - 1 vial of 2.5 mg/ml Albuterol Solution. Will continue to take, (site of inj. reaction expanded - red, size of baseball) feels hot.
I started noticing normal flu symptoms. Phlegmy throat; coughing and sneezing; congestion  in my throat and nose and some body aches. I did not have a fever. COVID-19 test - negative result at clinic. Road it out with no treatment - the symptoms lasted about a week and a half. All I have now is a stuffy nose. Had the flu vaccine - Had that around October 8 (around that week either prior or a bit after).
21 y/o male developed mildly pruritic pustular eruptions over UE and torso onset 8 days following vaccinations for SP, typhoid, AVA given 3/9/2010. No other systemic symptoms. Medically evaluated 3/19 at which time VSN, exam revealed erythematous papules over b/l upper arms, chest, most on back, few vesicles, few pustules, normal vaccine site on the right shoulder; no ecchymosis. Dx was dermatitis. Rx Allegra, ,Benadryl, Voltaren. Derm photos reviewed by director-clinical presentation and photos c/w non-IgE mediated reaction associated with SPV. By 3/22, SM improved, VHC recommended medical reactive exemption for future SPV in pre-exposure setting. Symptoms: Rash oth nonspecific skin eruption (782.1), Disturbance of skin sensation (782.0).
first dose>36 days; also received a dose of Pfizer vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (also received a dose of Pfizer vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose>36 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 19-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTRATION ERROR (also received a dose of Pfizer vaccine). On 19-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose>36 days). On 04-Feb-2021, PRODUCT ADMINISTRATION ERROR (also received a dose of Pfizer vaccine) had resolved. On 19-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose>36 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants were reported. No treatment was reported.
Patient is age 17 and current authorization of Moderna vaccine is 18 years of age and older.
It was reported, "A nurse reported that a 10 month old female, inadvertently, received Orimune and IPOL vaccines on 4/17/99. This report was received on the date of IZ. No adverse experience had occurred at that time."
Received vaccine on the afternoon of 4/4/01. That evening, he had a headache and spontaneous epistaxis. On 4/5/01, had epistaxis X 2 and a headache off and on. On 4/6/01, epistaxis X 1 but no headache.
Patient felt lightheaded after flu injection. Skin was pale/gray. BP=80/48 P=100 initially. Had patient lie down with feet elevated, BP=94/70 P=88 after a few minutes. EMS Called but she felt better by the time they arrived. BP=106/64. EMS evaluated but did not take to E.R. Patient went home with mother and told to follow up with own MD - no follow up needed.
Information has been received from a physician concerning a 21 year old female with no history of drug reactions/allergies, and a history of idiopathic thrombocytopenic purpura who on 9/25/06 was vaccinated IM with HPV vaccine (Lot 653735/0688F). There was no concomitant medications. In Sept 2006, a few days after vaccination the pt experienced a headache, nose bleed and developed thrombocytopenia. The pts platelet count on an unspecified date was 43,000. The pt was hospitalized and received platelet transfusion. A CT of the head and lumbar puncture were performed, however the results were unspecified. The pt subsequently recovered on an unspecified date. The reporting physician felt that one or more of the events was an other important medical event (OMIC) and life threatening. Additional Information has been requested.
I had 2 vaccines at the same time, first the Pfizer and the 2nd was for the flu (Fluad), that's the one that really hurt. I went home and 3 hours later I could not my arm, I put ice around, I took pain pills & Tramadol (50 mg), At 10pm I put more ice, I could not move my arm, the pain was deep inside. At 2am I get up and took another pain pill, I did manage to sleep a little bit, but when I woke up, I had headache, I took another pill called Sumatriptan, I slept until 5:30PM. I called my Pharmacy and they told me to take ibuprofen and to move my arm. This is the first time I experience this pain.
Mother stated to RN that patient developed a fever of 103 for 24 hours with administration of Tylenol and Motrin as well as uncontrollable crying. Mother did state prior to shots patient did have Rosella, but was recovered from illness before getting immunized.
Patient diagnosed with COVID-19 infection on 3/31/21, chest xray at that time unremarkable.  Patient presented to outlying hospital on 4/4/21 with worsening cough and nausea.  D-dimers were elevated and CT chest showed scattered airspace opacities.  Prescriptions for antibiotics and patient discharged from ED.  Patient again presented to outlying ED on 4/6/21 with worsening shortness of breath and nausea and poor appetite.  Patient was hypoxic saturating 86% on room air and was requiring 3L to maintain oxygen saturation.  Repeat chest x-ray showed mild-to-moderate bilateral airspace opacities.  Patient was admitted to outlying hospital on 4/6/21.  Patient transferred to this hospital on 4/9/21 with severe diffuse bilateral pulmonary infiltrates on CT chest and worsening COVID-19 infection.  Patient was treated with oxygen, antibiotics, remdesivir, and steroids.  Patient was discharged to home with new home oxygen.
Swelling, lump, warm and tender to touch, legs, upper thigh, site of injection left thigh.
Rash to face then spread to trunk, at ear lobe got swollen approximately 8-21-08. Seen 8-23-08. Treated with Benadryl 2 tsp every 4 hours prn for hives.
2:15 pm son awakens at nap time complaining of headache, tells preschool teacher. Standing in line for afternoon snack, he becomes pale and faints. Hitting his head nose and lip on ground of classroom. After coming conscious he vomits twice. Completely sheet white, skin, lips. Preschool calls 911 and myself. I arrive at preschool and ride with patient in ambulance to ER. We admit through ER and he is ruled with a reaction to immunizations, a head injury/concussion from falling. Discharged same night, no further diagnostics.