chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Hives around the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Tooth extraction (Patient stated that she had a tooth extraction due to infection and was on two different antibiotics and broke out in a rash.).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (Hives around the injection site). At the time of the report, VACCINATION SITE URTICARIA (Hives around the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include supplements.Treatment information was not provided. Patient stated that she experienced hives at the injection site after a week of receiving the vaccine.
Mild dizziness 4/26 at 9pm, vertigo at 4am on 4/27, followed by severe vertigo all day with vomiting. Vomiting occurred every couple hours with position change or standing. Unable to keep food or fluids down, notified OB at 1pm and was told it was likely vaccine reaction by triage RN. Symptoms persisted overnight, OB called again at 8am on 4/28 due to persistent vomiting. Instructed to go to ER. Received 2,000mL fluid, phenergan and Meclizine. I?m currently 15 weeks pregnant, due 10/16/21.
5 hrs /p DTP T went to 102-found unresponsive /c fixed stare-heart rate & resp normal-remained thus X 1 hr- T brought down & he became postictal thereafter. EEG 2 wks later-normal. No further seizures.
Very raspy voice, swelling of the throat, approximately 3 hours after injection lasted several hours, management had me go to the E.R., MD gave me ATARAX within 20 minutes swelling of throat and raspy voice went away.
This case received via the regulatory authority (reference number: 126746) on Aug 5, 2021, and forwarded to Moderna, reported by a consumer and describes the occurrence of product dose omission issue (second dose past 36 days) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 016B21A) for COVID-19 immunization. No medical history reported. On Mar 31, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 31, 2021, patient experienced product dose omission issue (second dose past 36 days). On Mar 31, 2021, product dose omission issue (second dose past 36 days): resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Left arm redness, heat and skin swelling. Measures 10.5cm long  by 7cm wide over the deltoid area of the left arm.
Extreme pain in injection arm, persisting months after vaccine was administered. Pt was unable to lift her arm above her shoulder. Was on anti-inflammatory medication PRN, then had to take around the clock to try to help manage the pain. She then went to her prescriber to get another medication to treat the pain. She says the pain is worse at night and she cannot sleep.
1st pregnancy test 1/17/03 neg. Vaccinated 1/17/03. Confirmation of pregnancy 2/7/03. EDC10/15/03.
It was reported that a 19 year old male pt received a Fluzone SV '00-'01 vaccination on 11/22/00 at 18:00. Reportedly, by the end of December 2000, the pt developed an onset of transverse myelitis. Treatment of 5 day "burst" of IV steroids and oral steroids was given. The pt required 5 days of outpatient hospitalization. The pt's recovery status was not reported. Further information is requested.
Admit to hospital 8/21/08. Fever, vomiting x 2 days - HA after receiving vaccine. Brother admitted with meningitis to same hospital 8/20/08. He also received vaccine 8/18/08.  9/26/07 Reviewed hospital medical records of 8/21-8/23/2008. FINAL DX: enterococcal viral meningitis Records reveal patient experienced HA x 2 days.  Seen in outlying ER where LP (+).  Older sibling admitted w/same.  Fever, increased respiratory rate.  Tx w/IV antibiotics & antivirals.  Improved & d/c to home.
Minor fatigue, acid reflux event, 5 days of low level gut ache, widespread skin sensitivity.
24-48 hrs p/vax w/vax extreme irritability, shrill cry 48-72 hrs hives & petechiae;
Patient woke up at 3:00 am the morning after her vaccine and vomited several times. She reports she could not keep food down for 8 to 12 hours once the vomiting started.
menstrual spotting a few days after injection; spotted again after the 2nd dose, a month later (April). please note that I have been post-menopausal for at least a decade.  I then experienced some vaginal bleeding for three days--like a  mini-period--each month in May, June, July, August, and September. don't know yet if I will have the same experience in October. I'm also wondering this: if I stop bleeding, does that mean I no longer have immunity to COVID-19?   also note: I had COVID-19 in 2020 and did not have any bleeding during or after the illness.
This spontaneous report was received from Pfizer and was assigned manufacturer report number 2015049186 for PREVNAR 13. On an unspecified date in November 2014, the patient was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown) (route, lot# and expiration date were not provided) since then he has had a splenectomy. The outcome of splenectomy was unknown. This was originally reported by a pharmacist. Upon internal review, splenectomy was determined to be medically significant. Additional information is not expected because the patient decline to provide information.
Complains of severe pain in left arm; difficulty in raising arm; area approximately 3 inch in diameter appears red and warm to touch. Very minimal swelling. Advised to use ice and antihistamine for redness.
The patient did not experience any symptom; One patient was vaccinated with improperly stored PROQUAD; Information has been received from a physician concerning a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications.  On 25-JAN-2020, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rha) lot # S002496 and expiration date of 23-JUL-2020, (route of administration and anatomical location were not reported) for prophylaxis, which was stored in the range of -9 to 8 Celsius degrees to (-7 Celsius degrees) for 50 minutes. The vaccine was reconstituted with sterile diluent(STERILE DILUENT).  No previous temperature excursion was reported.  The patient did not experience any symptom.   Digital data logger was involved.
Blurred vision, 2 x 2 red, warm at injection site burning sensation in chest and throat, hard to breathe, red blotchy skin at neck, face, ears. Tx: BENADRYL, epi, SOLU-MEDROL, IV with NS - doctor.
On 1/16/21, exactly one week after the shot, I developed an itchy rash, redness, and swelling on my arm under where the shot was given. The rash, redness and swelling has been becoming larger in size as the week progressed, and is still present today, 1/24/21.
Narrative: COVID infection following COVID vaccine series 02/02, Pfizer, dose #1 PRIVATE 03/08, Pfizer, dose #2 PRIVATE 03/08 pt cc: neck swelling/angioedma, dysphagia, dyspnea, edema,chest pain; admitted to non-facility hospital due to ADR 08/03 COVID swab, result: detected 08/03 pt cc: cough, fever, chills, body ache, back pain, chest pain 08/10 exposure: +COVID wife 08/17 COVID swab, result: detected 08/19 pt cc: confusion, slurred speech, right sided weakness, fatigue, near syncopal, progressive fatigue; admitted to hospital to r/o CVA 08/21 discharged from hospital after workup negative for CVA; dx: COVID encephalopathy 08/27 reports to PCP less falling asleep while sitting upright and breathing improved appts with Allergy and neuro clinic pending
First it started as retching/vomiting and diarrhea, which lasted about 2 weeks, then subsided.  Then a week after that stopped the patient reported having her first seizure that lasted about 5-9 seconds.  Patient reports falling to the ground and being unable to control anything.
Wrong vaccine given to patient. Box has meningococcal conjugate on box and was mistaken as meningococcal vaccine. Mother was notified within 30 minutes of error. No side effects.
One week after GARDASIL 9 was administered patient was still c/o pain, redness and knot to injection site.
fever; fatigue; chills; nausea; headache; head spinning; left arm painful at site of injection; This is a spontaneous report from a contactable nurse.  A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date as a single dose for immunisation.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the day after the vaccination, the patient experienced fever, fatigue, chills, nausea, headache, head spinning, and left arm painful at site of injection. The clinical outcomes of fever, fatigue, chills, nausea, headache, head spinning, and left arm painful at site of injection were unknown.   No follow-up attempts are possible; information about lot number cannot be obtained.
Initial unsolicited report received from physician on 10-Oct-2017. This case involves a 15-year-old male patient who was vaccinated with a single dose of FLUZONE QUADRIVALENT (Lot number: UI810AA, expiration date 30-Jun-18) in left deltoid via intramuscular route on 04-Oct-2017. The patient's medical history and concomitant medications were not reported. On 05-Oct-2017, one day following the vaccination, the patient developed 3x2 inch area with erythema, warmth, tenderness to touch, also had GI upset. The patient's laboratory data and corrective treatment were not reported. On an unknown date the patient was recovered from the events. List of documents held by sender: none.
I started having symptoms of a yeast infection and was also having some incontinence in August of 2022. I contacted my gynecologist through chat who recommended a cream that they had prescribed to me previously, but I had not used. Last week my symptoms were still occurring, so I went in for a visit. They diagnosed me with perhaps a yeast infection but found a growth of some sort right by my urethra. They want to wait and see if it resolves itself. If it does not, we will do an MRI and it may result in surgery.
This spontaneous report as received from a certified medical assistant refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-AUG-2016, the patient was inadvertently vaccinated with an expired dose of ROTATEQ orally, lot # K022990 with expiration date: 26-JUN-2016 (dose was not reported). There was no adverse effect reported. Product quality complaint (PQC) was not involved. Additional information is not expected as no contact details were provided.
PRIOR TO THE PFIZER VACCINE, I HAD MILD TINNITUS TO THE LEFT EAR ONLY. I RECEIVED THE INJECTION AT  AROUND 9:05 AM ON 05/22/21.   AROUND 3AM THE NEXT MORNING I WAS AWAKEN FROM SLEEP WITH SEVERE RINGING IN BOTH EARS. THE LEFT EAR  IS  5 TIMES WORSE  THAN BEFORE THE INJECTION AND THE RIGHT EAR IS NOW RINGING .  AFTER ALMOST 3 WEEKS THE RINGING HASN'T SUBSIDED.  IT INTERFERES WITH MY  ASLEEP, MY CONCENTRATION, AND MY HEARING.  I'M ALMOST AFRAID TO GET THE 2ND DOSE AS I CAN'T IMAGINE IF IT GETS ANY WORSE THAN THIS.
Pt received PNEUMOVAX 23 vaccine in the afternoon 10/02/2018. After the shot, Pt experienced discomfort at the injection site; took some ALEVE. Later afternoon the next day, 10/03/2018, tenderness and redness appeared, not at the injection site but around the injection area. Pt has been advised to consult with primary care doctor.
Chills during the early morning hours of 2/11.  Then body aches, fatigue, headache, nausea and vomiting.  Vomited at 6:30 am on 2/11.  Took acetaminophen with sip of water. Vomited at 12:00 noon.  Headache and fatigue continued through the day/night.  Was able to take Sumatriptan with one cracker.  Headache continued throughout 2/11 and into 2/12. Vomiting again on 2/12 at 8:00am.   Called MD to obtain zofran, took zofran and was able to keep it down.  Was able to sip 1/2 cup coke throughout the day.   Evening of 2/12 was able to keep 1/4 peanut butter and jelly sandwich down.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot # not reported). Subsequently the patient developed hypothyroidism. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Headache, Sedation, Myalgia, NauseaVomiting, chills and fatigue. pain at the injection site. Narrative:  Other Relevant History:
elevated HR, lots of anxiety, hives by injection site that went away the next day. high temp of 101 the next morning, headache and whole body hurts.
Shivering - started 8pm on day of vaccination, lasted until about 3am Tired, headache - started the morning following the day of vaccination and lasted all day
erythematous reticular patches on the upper back bilaterally/spread to beneath breasts and upper chests and arms; hand and lip swelling; hand and lip swelling; Pruritus started; previous areas turned into post inflammatory hyperpigmentation; rash became bullous at the edges, which were very sensitive to touch; rash became bullous at the edges, which were very sensitive to touch; This is a spontaneous report from a contactable other healthcare professional. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, in the left arm, on 09May2021 (at the age of 17-years-old) at dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any medication within 2 weeks of vaccination. The patient received the first dose of BNT162B2 via intramuscular route, in the left arm, on 18Apr2021 (at the age of 17-years-old) for COVID-19 immunisation. The events occurred over a period of 2 months since vaccination. Started on 16May2021, as erythematous reticular patches on the upper back bilaterally. It was not pruritic at this point. Spread to beneath breasts and upper chests and arms. At this point, in 2021, patient also developed hand and lip swelling. Pruritus started in 2021. Additionally, in 2021 rash became bullous at the edges, which were very sensitive to touch, and the previous areas turned into post-inflammatory hyperpigmentation. The events were reported as non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Prednisone was administered in response to the events. The patient was recovering from the events.    The lot number for BNT162b2 was not provided and will be requested during follow up; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Dizziness, sweaty and clammy. Patient was told to lie down for several minutes.
Left arm erythema and with urticaria over the body. I also had slight wheezing that resolved with albuterol MDI. The erythema lasted over a week and the urticaria resolved with an epi pen. I am ER nurse so I took care of myself without an ER visit.
COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP).  An 83-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 25Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "Malignant neoplasm of upper-inner quadrant of left female breast", start date: 01Oct2014 (unspecified if ongoing), notes: Date: 01Oct2014, Type: Primary, ICD-10: C50.212, Stg Date: 01Oct2014, Description: Breast Cancer (Breast Cancer) - Clinical Stage IV (AJCC v7) (TNM: cM1; ER Status: Positive: PR Status: Positive), Tx Setting: Metastatic, 1st Line, Status: Partial Response, Sts Date: 21Mar2019. Concomitant medication(s) included: PROLIA taken for breast cancer female, oestrogen therapy, start date: 21Mar2019 (ongoing); FASLODEX intramuscular taken for breast cancer female, start date: 10Apr2016 (ongoing); LETROZOLE, start date: 10Oct2014, stop date: 13Aug2015. Past drug history included: Bactrim, reaction(s): "Nausea"; Codeine, reaction(s): "Rash"; Keflex, reaction(s): "Rash"; Morphine, reaction(s): "Rash"; Oxycodone, reaction(s): "Rash". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The contributory role of the suspect product to the reported event drug ineffective and COVID 19 cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency. ,Linked Report(s) : US-PFIZER INC-PV202300018541 same patient/different drug/AE;
Approximately one week after the second dose of the Pfizer vaccine , I started to feel severe muscle aches , overall weakness and malaise . This lasted for approximately one month until the shingles on my scalp appeared . The rash subsided but now I suffer from post herpetic itch and pain .
Chills but no fever; Extreme fatigue; Inability to sleep; This is a spontaneous report received from a contactable reporter (Consumer). A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose; unknown lot number), for COVID-19 immunisation, reaction(s): "not report adverse side effects". The following information was reported: CHILLS (non-serious) with onset 17Mar2021, outcome "not recovered", described as "Chills but no fever"; FATIGUE (non-serious) with onset 17Mar2021, outcome "not recovered", described as "Extreme fatigue"; INSOMNIA (non-serious) with onset 17Mar2021, outcome "not recovered", described as "Inability to sleep". Additional information: The reporter mentioned that the adverse event started and ongoing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had a headache and fatigue after receiving the vaccine. I had a rash on my left arm after receiving dose one for over a week. In October 2022, I was diagnosed with Bell's Palsy. Also, after receiving the vaccine, my menstrual cycles changed for a couple of months. As of today, the menstrual cycles are almost back to normal, and Bell's Palsy has not changed.
3 days following injection, pt developed severe vertigo, headache, bilateral eye pain, weakness.  Pt advised to rest, hydrate and use APAP and/or ibuprofen for headache.  Pt declined in-person evaluation.  Symptoms improved within 24 hours.
Moderna COVID-19 Vaccine   Vaccine Lot Number:  025B21A  first dose. 9:25am dizzy and nauseous. started 5-10 mins after vaccine. Pt vitals were taken and monitored. pt was monitored and released after she was feeling better.  denied dif breathing or pain. 0940 153/78 p86 r16 pox 97%; 0950 124/77 P90 r16 pox95%
Pt explained that about 24 hours later she was so fatigued that she could barely get up to go to lunch, but she was able to go out to eat. By 4pm she had developed a high fever of 104 degrees Fahrenheit, her body ached, and she did not feel safe to drive. Pt called 911, but stated they would not come because it was not an emergency. Pt fell asleep at 6:30p and did not wake up until the next morning, pt believes she sweated all night long. The next day she felt better with some muscle aches, and residual fatigue. Pt is now beginning to itch, but does not have any marks. Pt declined an appointment, and will stay home and stay hydrated and rest. Pt did go to her morning aerobics, but is now going to rest. Pt will follow up as needed, but declined further care.
1 week after vaccination developed erythematous, circular, itchy, warm rash at injection site
Extremely achey Muscles & Joints ALL over with a pounding Severe Headache & Dry Mouth
Information has been received from a nurse practitioner concerning a 35 year old female with no relevant medical history and "allergy none" who on 25-JUN-2004 was vaccinated with a dose of MMR II. It was noted that on 14-JUN-2004, the pt received a SC dose on the left side of MMR II ( lot number 646124/0615N). There was no concomitant medication. There was no illness at the time of vaccination. On 25-JUN-2004, the pt developed a fever and swollen glands. On 26-JUN-2004, she had spots on the shoulders, upper chest and legs with itching. It was noted that the pt called with complaints of fever, swollen glands at the neck and spots on the chest and arms 29-JUN-2004. She was treated with Advil or Tylenol as needed. The pt recovered on 02-JUL-2004. Unspecified medical attention was sought. There was no product quality complaint involved. No further information is expected.
pt recv vax 1APR96 & 19APR96 pt devel 20 pox on back, face & chest;mom stated was afeb, acting nl & that the pox lesions didn't seem to itch too bad;pt devel a total of 32 pox which were mostly on trunk;
About two hours after I received the Yellow Fever Vaccine, I got dizzy, got a severe headache, became light sensative, and started seeing incorrectly (I was seeing things that were to the side as if they were in the front). My sister and I were traveling and had to get a hotel room so I could lay down in the dark. I got chills and had to stay wrapped up in blankets to stay warm. The severe symptoms passed after about 8 hours but the headache lingered for several days. I did not receive any treatment. We just waited it out in the hotel room.
This patient was given Hepatitis B, left deltoid at 2PM. Per mother the patient complained of symptoms of shortness of breath, throat closing, clammy, pale. Seen in ER given, IV fluids, and Benadryl at 6 PM; home at 9PM.
pt. contacted provider on 6/4/21, stating he has pain in his left shoulder. He stated he felt like the vaccination was given to high and he took a picture of where the nurse placed the band-aid. Director verified if band-aid was the actual place of injection the vaccine was given to high and could have caused SIRVA. Pt stated his shoulder was fine after injection and it was over two weeks post injection that he started to feel shoulder pain.  On  6/10/21 pt stopped by vaccination clinic and informed staff his pain was worse and was now causing pain down his arm to his wrist. Nurse informed pt to see his physician.