chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Given bivalent booster dose as 1st dose of primary series; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Given bivalent booster dose as 1st dose of primary series) and NO ADVERSE EVENT (No adverse event) in a 48-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027E22A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 25-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Given bivalent booster dose as 1st dose of primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Given bivalent booster dose as 1st dose of primary series) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Given bivalent booster dose as 1st dose of primary series).    The concomitant medication was not reported by reporter. Nurse reported that in one of their clinics, another nurse inadvertently gave the bivalent booster dose as a 1st does in the primary series today, 25-Oct-2022. This was given at 0.5 ml intramuscularly. The treatment medication was not reported by reporter.
12 hours later I woke up in a cold sweat. I couldn?t sleep, had severe chills but felt very hot, slight fever, very bad inner ear burning, headache in temples + front and back of head. Severe skin sensitivity, light and sound sensitivity. Severe muscle aches and can?t really get out of bed.
sleeping the first night and then started to sweat; sleeping 24hrs; swollen arm; swollen arm and it was red; Fever; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (sleeping the first night and then started to sweat), HYPERSOMNIA (sleeping 24hrs), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (swollen arm and it was red) and PYREXIA (Fever) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040AZ1A and 028Az1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient confirmed testing positive for COVID-19 and mentioned it lasted for 6 weeks and she has lost taste and smell.) in March 2020. Concurrent medical conditions included Blood pressure abnormal.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced NIGHT SWEATS (sleeping the first night and then started to sweat), HYPERSOMNIA (sleeping 24hrs), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (swollen arm and it was red), PYREXIA (Fever), CHILLS (chills) and NAUSEA (nausea). On 10-Mar-2021, HYPERSOMNIA (sleeping 24hrs) had resolved. On 13-Mar-2021, PYREXIA (Fever) outcome was unknown, NAUSEA (nausea) had resolved. At the time of the report, NIGHT SWEATS (sleeping the first night and then started to sweat), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (swollen arm and it was red) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       After the first vaccination patient experienced a fever and was sleeping the first night, then started to sweat, chills, and had some nausea. She also had a swollen arm and it was red. She wants to know if these symptoms are normal, is she still contagious after the first dose only, and are the symptoms she is experiencing have any correlation with the fact that she had COVID-19 this past March2020.  Treatment information was not reported.   This case was linked to MOD-2021-136663 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up received on 17-May-2021 and included significant information such as suspect vaccine Lot Number and start date was added, New event was added, medical history was updated, Outcome of the events nausea and fever were updated.
he reported that on 02JUL2021 a patient was administered ROTATEQ that expired on 03JUN2021; no adverse event; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant therapies, drug reactions, or allergies was not reported.     On 02-JUL-2021 the patient was vaccinated with an expired 2 ml dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) for prophylaxis (lot number: 1684142  and expiration date: 03-JUN-2021) (vaccination scheme frequency were not reported). No adverse event was reported.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A male patient received unknown dose number of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Apr 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced tremors (really bad tremors), onset Apr 2021, with outcome of unknown. Additional information: Patient received COVID-19 vaccine yesterday. Last night he had really bad tremors to the point he couldn't even hold a glass of water. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
This spontaneous report received from a medical assistant referred to unspecified patients of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. Medical assistant reported that on unspecified dates, multiple, unspecified patients received improperly stored doses of ROTATEQ (lot: M031802; expiry: 09-NOV-2017 and lot: M011832; expiry: 25-JAN-2018). No adverse effects reported. There had been three excursions for ROTATEQ (lot: M031802; expiry: 09-NOV-2017); 35F for 6 days, 35F for 5 minutes and 35F for 5 minutes. There had been two excursions for ROTATEQ (lot: M011832; expiry: 25-JAN-2018); 35F for 5 minutes and 35F for 5 minutes. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA006670:same reporter.
Itchy, painfully, swollen and hard patch  at injection site   Started on the night of June 16th
patient was administered and expired dose of ROTATEQ; This spontaneous report has been received from a licensed professional nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, current conditions, previous drugs reactions or allergies and concomitant medications were not reported.  On 07-APR-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot number 1707449 has been verified to be valid, expiration date: 28-MAR-2022), administered orally for prophylaxis (expired product administered).
Patient received vaccine on 11Jun21 at 0800.  Patient waited recommend 15 minutes of observation without any issues, later started to develop symptoms (sore throat and dizziness).  Arrived ER 1050, given meclizine 25mg and discharged 1215. Patient rec'd the covid vaccine at 0800 and c/o dizziness and sore throat. Dx given as Vertigo. He is scheduled for appt in facility tomorrow for f/u of MRI results
Pt recvd 2nd dose of vax on 29JUL92 & w/in 24 hrs following the vax devel a nonconfluent petechial rash on legs, arms, chest, trunk, back & face;
profuse sweating; felt unwell; pain in stomach; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on the left arm on 03Mar2021 at 17:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and surgically induced menopause. The patient had sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Other vaccine the patient received within four weeks prior to the vaccination included tetanus vaccine toxoid/ diphtheria vaccine toxoid/ pertussis vaccine acellular (TDAP) via an unspecified route of administration on the right arm on 15Feb2021. Concomitant medications included bupropion (MANUFACTURER UNKNOWN); levothyroxine (MANUFACTURER UNKNOWN) and estradiol (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On 04Mar2021 at 13.30, 20 hours to 20.5 hours after vaccination, the patient experienced profuse sweating, felt unwell and pain in stomach. Diarrhea began 21 hours after injection and was still continuing at 26-hour mark. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events profuse sweating, felt unwell, pain in stomach and diarrhea were not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
For a second she couldn't breathe; Threw up; Chills; Dizziness; Headache; Body ache; High fever; Neck hurting; Head exploding; Ears popping; Exhausted all night; Did not sleep; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0179 and expiry date was unknown) via an unspecified route of administration in left arm on 10May2021 09:13 (at the age of 46-years-old) as dose 2, single for covid-19 immunization. Patient medical history included reaction to penicillin from 2002 (Had the Penicillin pills from; back home-there they just gave penicillin shot in leg; they just gave Penicillin pill, and the reaction was hives). Patient had ongoing food allergy. It was reported that patient had these from many years ago. Patient concomitant medications included vitamin d nos as the patient has low vitamin D (had been taking for may be 4-5 years or more, from a long time). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0170) via an unspecified route of administration in left arm on 19 Apr 2021 around 13:15-13:30 (at the age of 46-years-old) as dose 1, single for covid-19 immunization. No additional vaccines administered on same date of the Pfizer Suspect. Patient had no family medical history relevant to adverse events. Patient had not received any other vaccines (within 4 weeks) prior to the first administration date of the suspect vaccine other than dose 1 of 2 of Pfizer Covid-19 Vaccine. No adverse events following prior vaccinations. Patient stated that she received the first dose of Pfizer Covid-19 Vaccine on 19Apr2021, and she did not have any adverse events after the first dose. On 10May2021 19:00, patient reported that after receiving the second dose she experienced chills, dizziness, headache, body ache, high fever, neck hurting, head exploding, ears popping, exhausted all night because she did not sleep; could not breathe for a second, threw up on 11May2021around 00:00 or before 00:30. Patient reported on 11May2021 morning around 10:30 she kind of left the bed, decided was going to do something, moved around and felt a little better. Around 13:00 she took a Tylenol, which she waited until over 24 hours after she got the Pfizer Covid-19 Vaccine to take. Patient stated she was doing much better now. It was reported that the adverse event did not require an emergency room or physician office visit. There were no relevant tests. Outcome of the events exhausted all night, did not sleep was recovered on an unspecified date in 2021, and the rest events were recovering at the time of report.  No follow-up attempts are needed. No further information is expected.
The patient was "off schedule" when receiving GARDASIL 9; No adverse effects were reported during the call; This spontaneous report was received from the patient's mother, referring to her son, a male patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.      On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of vaccination, lot # and expiration date were not provided) for prophylaxis.         The patient's mother stated that, on an unspecified date, the patient was "off schedule", when he was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No adverse effects were reported.
Two days following injection: Right (non-injection side) forearm and hand soreness/sensit; Upper left arm (injection site) slight soreness day of injection.; This is a spontaneous report from a contactable other healthcare professional (hcp) (patient). A 30-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 23Dec2020 11:00 at a single dose in left arm for COVID-19 immunization. Medical history included severe neutropenia, arthritis in neck, osteophyte in neck. No known allergies. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). No other vaccine in four weeks provided. On 23Dec2020 12:15, the patient experienced upper left arm (injection site) slight soreness day of injection, slight increase in soreness here and in left back area near left underarm the following day, two days following injection in 25Dec2020: right (non-injection side) forearm and hand soreness/sensit. None of the aforementioned events have been more than mild in severity. This is non-serious report. The patient had no COVID prior vaccination and no COVID tested post vaccination. No treatment received for this AE. The outcome of events was not resolved.  Information on the batch/lot number has been requested.
Immediately after administration of the vaccine, the patient fell onto the ground and experienced tonic clinic seizure activity for approximately one minute and 30 seconds, including eyes rolling to the back of head and jerking motions of all extremities. Patient was taken to hospital via EMS.
she got a little dizzy; This morning around 4:00 she was getting up to go to the bathroom and she was feeling a swimming feeling in her head when she was about to stand up; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 17Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had the first dose of the vaccine on Wednesday, 17Mar2021 and didnot have any problems then but yesterday (20Mar2021 04:00) she got a little dizzy. This morning around 4:00 she was getting up to go to the bathroom and she was feeling a swimming feeling in her head when she was about to stand up. She stated it was kind of scary. She asked if this is a normal side effect and what she should do about it. She said she saw dizziness on her paper as a potential side effect. The outcome of the events was unknown.  Details: Originating AE Request: REQ-201563; Request Name: REQ-201563  Information on the lot/batch number has been requested.
Post vaccine 11 hours, severe sore arm at injection site, 101.6 fever (tympanic), chills, body aches, headache, fatigue, sleepiness. Fever lasted 48 hours plus body aches and chills then went away. Still present are minor sore arm at injection site, headache, fatigue, weakness, sleepiness.
Patient has hives 30 minutes after vaccination. Patient states she found out she's allergic to oat this morning after having oatmeal for breakfast (she broke out is hives and itchy mouth). After her hives died down she came in to get her vaccine then had hives again 30 minutes after. She took benadryl and felt better after.
Fever for about 36 hours, headache, sore, red, hot, swollen arm, joint and muscle aches.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Medium, Systemic: Sweating-Medium
No adverse event but an extra dose given to the patient. Member was observed after vaccination and no complications surfaced. Dr. contacted for further treatments and recommendation and Dr. recommends that since patient already received vaccine there was nothing that can be done at the time but to observe for any allergic reactions.
Around 9pm on August 14, 2021, I started to run a fever and felt a heaviness in my chest. I assumed these were just a sign of the vaccine kicking in. I went to bed to try and sleep it off around 11pm. When I awoke the next morning (August 15th) around 8 am, I saw that my face and lips were swollen and my chest was still heavy feeling. I placed a call to my healthcare provider on their emergency line to let her know what was going on. It was recommend that I take a steroid and  Benadryl or antihistamine to alleviate the symptoms. I was told to go to ER if symptoms got worse or to follow up in the office on Monday if it wasn't emergent. I took a dose of Dexamethasone around 9:45am. I then followed that around 11 am with a Zyrtec. I took Benadryl around 10pm on August 15th. By the time I awoke on Monday, August 16th, my symptoms had subsided.
High fever up to 102.4 on 9/27/12 in the am.  Exhaustion.  Swollen right lower calf with rash on 9/28/12.  Patient is still ill so outcome is not finalized.  Full recovery expected.
Pt received Moderna vaccine on 8 Apr.  Had partial complex seizure w secondary generalization 9APR c/b tongue bite and bleeding requiring intubation for airway protection. Admitted to hospital, tongue lac repaired, CT w/o evidence of CVA. Transferred to MC 10APR. Pt was extubated, had a normal EEG, MRI brain, and discharged home.
Pain/deep pain in the chest, hypertension, SOB.  Was seen at Hospital ER where they did lab work, EKG, and CXR.  Employee's symptoms resolved while in the hospital and employee was realeased home and back to full duty.
Very annoying tinnitus.  Had a small amount before the but greatly increased after the vaccine and has still not abated.  It has been 4 months of suffering now and I am afraid to get the second shot.
Information has been received from an investigator during a study concerning a 64 year old female with a history of osteoporosis, elevated blood pressure, hyperlipidemia, atrial fibrillation in the past and recurrent dyspnea of uncertain etiology who on 25-JAN-2007, was vaccinated with ZOSTAVAX (Oka/Merck) (Lot# 652936/0981F).  The patient did not have concomitant vaccines.  The patient had sustained a recent lower back injury at work and was being seen by occupational medicine.  She was not anticoagulated.  She was last seen by her medical provider on 25-JAN-2007, the day of vaccination, and was doing well.  The patient suddenly expired on 04-MAR-2007.  Her death certificate gives cause of death as cardiac arrest and cardiogenic shock.  A lot check has been requested.  This is one of several reports received from the same source.  Additional information has been request.  11/5/2008 Death Cert and  note received from FDA. Pt expired suddenly on 3/04/2007. COD Cardiac Arrest and Cardiogenic Shock.
Beginning a few days after the first vaccine I began experiencing a flood of discharge (had never happened before).   It occurred for 3-4 days and was so significant I had to wear a pad. This stopped once my period started, but shortly after my period I began to get consistent cramping for over a week (long enough that I made a doctor's appointment, and the doctor had me make a follow-up ultrasound appointment). In the end my next period came 5-6 days early.
A day after the injection, I developed severe pain in my lower back that radiated down my legs to my feet plus median nerve pain in both hands (I'm a violinist and both carpal tunnels were released in 1985) .  It did not resolve with aspirin.  Opioid painkillers were necessary throughout the night.  The next morning, I was placed on a 15/10/5 prednisone taper.  It had been previously determined that 20 mg/day of prednisone would not interfere with immune formation.  The symptoms resolved.  One day after finishing the prednisone, they returned.  I did another 15/10/5 taper.  Two days after finishing it the symptoms returned and I went on a 35/30/25/20..... etc. taper.  Less than a week after I finished that (on April 14 around 5:00 p.m.) the symptoms returned and I was placed on 25 mg/day of prednisone for five days, then a 20/15/10/5 taper.  Today is the last day of that taper.  I am waiting to see if the symptoms return.
Erythema and swelling of left thigh. Erythema 12cmx8cm.
This spontaneous report as received from a physician assistant via a company representative refers to 2 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the doses of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). On unknown dates (reported as in the last few years), the patients were diagnosed with shingles, after the receipt of ZOSTAVAX. The outcome of shingles was reported as recovered on unknown dates. The relatedness between the adverse events and ZOSTAVAX was not provided. Additional information is not expected as the reporter did not wish to be contacted.
Injection 10/1/18; Patient has BMI 20.2 On 10/5/18 call received from patient about redness and mild pain at site of injection. On 10/16/18 call received from patient about continued pain in left shoulder attributed to flu vaccine; specifically, patient believed injection was given too high in his arm and that this caused SIRVA which appears to be an abbreviation for "shoulder injury related to vaccine administration". Patient has not yet been seen in clinic but will be seen 10/22. Patient was unable to come in on date of report.
A day after receiving his vaccine (April 1) he started developing chest pain, described as squeezing substernal pain, with palpitations.  He also had some fever, chills, body aches and headache in the first 24 hours following the March 31 vaccine. He was admitted to the hospital on April 2, and discharged from the hospital on April 5 He had ST elevations on ECG, troponin of 12,891, echocardiogram showing ejection fraction of 45 to 50% with inferior wall motion abnormality. By hospital discharge, his chest pain symptoms had resolved.  He did not develop any tachyarrhythmias, ectopy, or heart failure symptoms.  He will have a cardiac MRI scan as an outpatient and close follow-up with cardiology.
Mom reports Pt was taken to the pediatrician on the same day of health dept visit for a rash after vaccination. Mom reported this to the clinic on her return for further vaccination on 9.7.23. Mom reports pediatrician advised for the child not to receive the Quadracel combination in future.