chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10-04-06 3:45 p.m.was running and became nauseated, dizzy. 10:00pm throat became sore when swollowing. Muscles in neck were sore/stiff ("like when you sleep wrong on neck") 10:30pm Hives on back, stomack, neck, and shoulders) chills until 2:30pm 10-5-06 a.m. few hives on shoulders. no nausea. neck aches/stiff. Instructed to see physician as soon as possible. Noted will see her doctor this morning.
Pt-received a VARIVAX booster-sq-left arm 3-5 minutes later she fainted-hit back of hand on floor. She was with her mom and sister. 911-called-they checked her out-Parents decided not to go to hospital via ambulance-Pt was up walking-no pain-no numbness-just light headed.
Pt recvd 2 doses of Engerix-B & devel a fever on 13JUL92 p/2nd dose; diminishes w/APAP but recurs in the afternoon of the following day;
pt recv vax 21OCT97 & exp sx of n/v, raised temp 3 days p/vax;tx w/phenergan & sx resolved;
This spontaneous report as received from a other health professional refers to a 17 year old female patient with vestibular disorder, drug hypersensitivity, food allergy and cochlea implant. On 14-MAR-2017 the patient was vaccinated with GARDASIL 9 lot # M034780 for prophylaxis. Other suspect therapies included MENVEO. Concomitant therapies included albuterol (ALBUTEROL). On 14-MAR-2017, 1 day after onset of therapy the patient experienced rash and dysgeusia. On MAR-2017 the patient experienced neck pain and hypoacusis. The outcome of rash, hypoacusis, neck pain and dysgeusia is unknown.
Injection site redness approximately nickel sized. Redness began 09/30/2022. Injection site swelling approximately nickel sized in diameter at time of reporting 10/01/2022 . Swelling began 09/30/2022. Pain in right arm pit as of Saturday 10/01/2022. Diarrhea. Began 10/01/2022.
Acted out a vivid nightmare and dove face-first off the bed onto the floor. Fell on a large flashlight by the bed and bit through my tongue, split my lip, and had a huge black eye that covered the right side of my face for two weeks..
2 hours after vaccination with KINRIX, swelling and redness at deltoid. Treated with BENADRYL.
Right after the vaccine muscle aches, chills, I felt extremely warm, but I did not have a fever, and fatigue. This lasted for about 2 days. Towards the end of my side effects, I did have a headache as well.
5/10/07 Pt called with c/o chest tightness and a local reaction the size of a goose egg from her JE shot. The injection site was 'red w/a wheel in the center. Pt was referred to ER/PCP. 5/16/07 pt called to F/u stating she went to the ICC on 5/10/07 and received an epi and cortisone shot along with a breathing treatment and for Bronchospasms. Pt was also finishing a steroid dose pack and taking Zyrtec. Pt stated she had lip swelling on 5/11/07 and got injected with epi pen.
11/16/21  Started 2 days ago with congestion and headache.    ROS:  Const: Fever: No, Chills: Yes, Body Aches:  Yes ENT: Ear Pain :No, Sore Throat: Yes, Nasal Cong: Yes Resp: Cough: No GI: Nausea:Yes, Vomit: No, Diarrhea:No     Neuro: Headache:   Yes
Mild symptoms from first shot; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Mild symptoms from first shot) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2020.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Mild symptoms from first shot). At the time of the report, VACCINATION COMPLICATION (Mild symptoms from first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided by reporter. Treatment information not provided by reporter.   This case was linked to MOD-2021-294314 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Patient demographic details were added and route of administration of vaccine was added On 30-Aug-2021: Follow up received on 30- AUG-2021 contain non-significant information.
Redness, swelling of left upper arm - fever - 100deg - redness 5.0 x 9.00cm; Tx with ice/Tylenol or ibuprofen
Tested postive for COVID -19; This is a spontaneous report from a contactable consumer reporting on herself. An 81-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was Not available/provided), via an unspecified route of administration on 18Feb2021 14:30 as SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. The patient had no previous allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines in four weeks or any other medications in two weeks. The patient tested with positive for COVID -19 (sars-cov-2 test positive) on 22Feb2021. The event resulted in Emergency room/department or urgent care. The patient did not receive any treatment for the event. The patient underwent lab tests and procedures which included Nasal Swab and Rapid PCR with positive result on 22Feb2021. The outcome of the event was unknown.  Information on the batch number has been requested.
A 27 year old woman, who is a nurse at the health care provider, received an injection of MassBiologics' Td vaccine (Lot #A090A) on October 25, 2016 intradermally in her left forearm instead of being administered PPD. The patient experienced same day onset of injection site pain, erythema, and induration. At the time of the report, one day post-administration, the patient had not recovered. Treatment of the event was not reported.; Sender's Comments: All adverse events reported in this case were assessed as non-serious and labeled, consistent with local injection site reactions causing tenderness, erythema, and induration described in the Td vaccine package insert.  The Td vaccine was administered incorrectly. MassBiologics (Sender) performed a follow up with the primary source reporter on one occasion as summarized below: Follow up on November 28, 2016: The reporter informed MassBiologics over the telephone that the patient's reactions had resolved completely. When queried about the dose, the reporter (and person who administered the vaccine) indicated that the administration error occurred because she did not read the product label completely and confused it with PPD. The reporter clarified that she administered the dose for PPD and not the full Td dose. Please note that report 'US-MassBiologics-AE1607' has been linked to this report. The events were similar events and were reported to MassBiologics at the same time by the same primary source reporter for the same Td lot. In the linked reports, both patients worked at the provider's office as nurses and were also the individuals that administered the doses to each other.
Dizzy off balance ever since getting; Dizzy off balance ever since getting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2021 at 12:00 as dose 2, single (Lot number: Er8737) at the age of 42 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8737), for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious), BALANCE DISORDER (non-serious) all with onset 2021, outcome "unknown" and all described as "Dizzy off balance ever since getting". The event "dizzy off balance ever since getting" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information- The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient tested for COVID-19. Device Date: 01Jul2022  No follow-up attempts are needed. No further information is expected.
sensory symptoms in Lower extremiteis, ascended upwards, followed by motor weakness L>R
Medical assistant administered the vaccine past the BUD (17Feb2023); no adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Medical assistant administered the vaccine past the BUD (17Feb2023)) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history/conditions, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis).     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Medical assistant administered the vaccine past the BUD (17Feb2023)) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Medical assistant administered the vaccine past the BUD (17Feb2023)) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Medical assistant administered the vaccine past the BUD (17Feb2023)).    It was reported that the patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. It was reported that the Medical assistant called to report that they administered some vaccine past the BUD (17-Feb-2023) to 20 patients. HCP  was looking for the viability of the vaccine. The vaccine was administered between 13-March-2023 to 05-Jun-2023. The patients received the vaccine either as the 3rd, 4th or 5th dose. No treatment medication was reported. This case contains information for the 3rd of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master case
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies, or concomitant therapies were not reported. On 13-JUN-2017, the patient was vaccinated with an expired dose of VAQTA injection (dose was not reported) lot number M034896 and expiration date 26-MAY-2017 for prophylaxis. No adverse effects were reported. Additional information has been requested.
I received my first dose 5/21/2021 - The next day I experienced - a low fever, muscle aches, joint pain, chills, diarrhea, and I was very fatigued. The pain kept me awake, but I was exhausted. The diarrhea was pretty awful, but I stay hydrated and it stopped after a couple of days. I felt like I had a stomach flu, just overall pretty awful. On top of that my legs swelled up to twice their normal size. I contacted my doctor to inform them of that particular side effect, but it was decided to not be an emergency due to the fact the swelling was symmetrical and would come and go with activity. These side effects ruined what little quality of life I have left in my disabled life. It's definitely less than ideal.   When it was time for the second shot, the vaccination nurse turned me away after I told her about my side effects. I had to go to my doctor and get a note to receive the second injection. That was when I got my first antibody test to see if I could avoid the second injection all together. No such luck. After some deliberation, my doctor and I decided that the pros outweighed the cons if I could get some immunity from the second shot, so we took the gamble. It did not pay off. A couple of weeks after my second shot my doctor tested me for antibodies again and I tested negative again.   Unfortunately, the second shot gave me a stronger set of side effects than the first, from which I had not fully recovered, and I now live with continuous painful swelling in my legs that I can't control even with compression socks. I have a persistent dry cough that won't go away. I am exhausted even more than I have been since I became disabled due to my autoimmune conditions and I can't seem to get any sort of restful sleep. Now, despite the fact that my husband and I are in complete quarantine, I have developed bronchitis. We haven't gone anywhere. None of my family can come visit because my health is too fragile.  I do telehealth appts due to my health. I have no idea how I got sick. I think that the vaccine has stressed my body to this point.
pt recv vax 11APR97 & was given APAP;pt devel swelling & redness since 5PM & was crying, seen in ER;
Injection Wed. Slight bone aching Wed night. Good Thur with slight arm soreness. My son woke me about 3 AM Thurs night.  I had to lay back down due to  fast heart rate and feeling of nearly passing out.  Happened 2 times. Friday day was ok. Same thing happened Friday night and Saturday I felt bad all day with episodes lasting longer periods and BP was elevated with highest checked  166/104. I had some aching between shoulder blades and left arm.  Mild to moderate headaches  each day.  I did not  contact doctor. I have a special needs son with no help on weekends or nights. I feel better today. Heart rate went from  69  to 131 at one point when checking.  I sit or lay until it lowers and then slowly get up to do what is needed. Head ache today. But I also stopped my caffeine which is normally 2 cups a day. BP IS 138/93 now with sitting.
Persistent pain at site and persisting over (4 wks) time. Sharp pain worsened by movement. No redness. No fever. No chills.
Patients arm is swollen, red , painful, and hot to touch approximately 2 inches below injection site. Patient complained of high temperature the day of injection and pain at injection site. Reaction below the injection site developed 2 days after vaccination. Patient was advised to contact physician and has an appointment with physician this afternoon.
I woke up on 4/3 at 8am my chest and breast area was red and itchy and it had worsened through out the day. It burned and it had already spread. I contacted a doctor and he prescribed Steroid pills and Cortisone cream. The rash went away on its own 1 month later.
Moderna Booster (0.25ml) vaccine was drawn up after max 20 drawn doses allowed . Proper aseptic techniques were used during dose extraction and dose was inspected prior to administration. Patient was given correct dose (0.25ml) and was monitored for 15 minutes after vaccination. No adverse event/reaction occurred after administration.
Cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough). At the time of the report, COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  No treatment information provided.  The reporter did not mention any adverse events but did cough a few times during the call.
Phone call from mother, stated child had a fever of 101.2 on 9/24/2019 and had to be picked up from school.  Patient had not had any antifebrile medication today.  Child states head hurting and arm hurting.  No seizures or any other symptoms noted.  Encouraged Tylenol or Motrin for symptoms along with ice pack to arm.  Instructed mother to call pediatrician if patient becomes worse or if symptoms do not improve.
Information has been received from a physician concerning a 15 month old male who on 18-JUN-2007 was vaccinated subcutaneously in the left thigh with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot# 657412/0594U). Other vaccinations given on the same day included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and Prevnar. On 25-JUN-2007, the patient developed a "rash on the face and hand". On 29-JUN-2007, the patient developed a "rash on the left cheek and dorsal aspect of left hand". The physician reported that "the rash was 6 to 8 red papules on left check and left hand. No vesicles present." The patient recovered. There was no product quality complaint involved. Follow-up information from a health professional indicated that on 25-JUN-2007 the patient developed lesions. He was seen at the office on 29-JUN-2007 and he had 6 to 8 red papule lesions on his left hand and cheek. It was to be atypical chickenpox. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
4 days after the second vaccine I became ill with flu-like symptoms - chills, violent shaking overnight, fever elevation of 2-3.5 degrees, muscle aches, and fatigue.  Symptoms lasted for 2 days.  There were no gastrointestinal or rhinological symptoms.
Fever; headache; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Apr2021 10:00 (Lot number: ER8732) at the age of 49 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "Allergies: pcn" (unspecified if ongoing); "sulfa" (unspecified if ongoing); "severe adhesive allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cephalosporin, reaction(s): "Drug allergy". Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number= EN6207, prev dose lot unknown=False, prev dose dose number=1, prev dose vaccine location=Right arm), administration date: 12Mar2021, when the patient was 49 years old, for Covid-19 Immunization, reaction(s): "Headache", "Fatigue". The following information was reported: PYREXIA (non-serious), outcome "recovering", described as "Fever"; HEADACHE (non-serious), outcome "recovering", described as "headache"; FATIGUE (non-serious), outcome "recovering", described as "fatigue". The events "fever", "headache" and "fatigue" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, headache, fatigue.  Additional Context: Fever over 104, not able to reduce with medication below 101, severe joint pain through back and hips, headache, chills, brain "zaps", Extreme fatigue. All symptoms Lasting over 24 hrs. After 24 hrs, severe joint pain remains. First dose had a headache and fatigue for a few hrs. 2nd dose fever, headache, fatigue for 6-8 hrs. 3rd dose makes me never want to get a 4th if recommended.  Follow-Up (13Jan2022): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Large, flat erythematous, warm, pruritic patch B/L arms following vaccine administration. (L) arm lesion 4cm diameter. (R) arm lesion 2.5cm. Advised BENADRYL and heat.
Vaccine administered subcutaneously in patients R thigh as patient was being restrained by parent. Patient was resisting vaccination, and vaccine administered at possibly narrow angle. Vaccine administered left small raised area.
Complained of face swelling and redness.  Swelling at injection site 1 hour after injection.
Started feeling poorly about 9 hours after the vaccine. Chills, nausea, dry heaves, body aches, head ache, low grade temp, sore arm at injection site. Felt really bad for about 72 hours
pain at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
The patient came in to get the flu shot. The pharmacist administering the vaccine misunderstood which vaccine the patient wanted and administered the Janssen COVID vaccine instead.
PATIENT WAS GIVEN THE MODERMA VACCINE FOR HER SECOND DOSE . SHE HAD THE PFIZER VACCINE FOR HER FIRST DOSE ON 2/19/2021.  SHE WAS OBSERVED FOR 15 MINUTES WITH NO ILL EFFECTES.  CONTACTED THE PATIENT AT 6:30 PM ON THE SAME DAY, AND SHE HAS HAD NO ADVERSE EFFECTS.
Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of ZOSTAVAX (lot # not reported) by the intramuscular route. No adverse effect reported. Follow-up information was received from a registered nurse which reported that the 67 year old patient was a male who was vaccinated IM into the left deltoid with a first dose of ZOSTAVAX (Oka/Merck) (lot # 662859/1561X) at 10:15 am on 23-DEC-2008. There was on illness at the time of vaccination. It was reported that on an unspecified date the patient developed a sore arm that last for 3-4 days. No other symptoms. No relevant lab tests were performed. At the time of reporting, the patient's outcome was unknown. Follow-up information was received from the R.N. on 19-FEB-2009 which reported that the patient was a female. Her vaccine was given at 10:00 am, 23-DEC-2008. The patient had a joint problem in shoulder prior to the injection. The reporter stated that on 19-FEB-2009, "talked to the patient today and muscle was fine, no redness and soreness". The patient recovered on an unspecified date. No further information is available.