chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inappropriate schedule of vaccine administered; Menstrual cycle - increased cramping, heavier than normal bleeding; Menstrual cycle - increased cramping, heavier than normal bleeding; Menstrual cycle - increased cramping, heavier than normal bleeding; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Apr2021 15:00 (Lot number: ER8736, Expiration Date: 31Jul2021) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19,, brand=Pfizer,, brand unknown=False,, lot unknown=True,, lot unknown reason=Not available/provided to reporter at the, time of report completion,, administration time=03:00 PM, dose number=1,, vaccine location=Left arm), administration date: 31Mar2021, when the patient was 41 years old, for COVID-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious), DYSMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious) all with onset 14Apr2021, outcome "recovered" (Jul2021) and all described as "Menstrual cycle - increased cramping, heavier than normal bleeding"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 14Apr2021 15:00, outcome "unknown", described as "Inappropriate schedule of vaccine administered". Therapeutic measures were not taken as a result of menstrual disorder, dysmenorrhoea, heavy menstrual bleeding, inappropriate schedule of product administration.  Additional Information: It was reported that, the patient had no Known allergies. No other vaccine in four weeks. No other mediation in two weeks. No covid prior vaccination. No covid tested post vaccination. The patient did not receive any treatment for the adverse event.  No follow-up attempts are possible. No further information is expected.
Fever of 102, stomach pains, body aches, chills--fever and aches went away--2/8 stomach pain is still lingering
Patient received Moderna vaccine on 5/14/2021 and then came to Facility and received a dose of Janssen.  Not a patient of Facility were unable to contact patient to clarify if there was a reason why this happened.
This spontaneous report was received from an unspecified reporter and refers to a 41 year old female patient. The patient concurrent conditions and medical history was not reported. Historical drug included extreme flu influenza vaccine (manufacturer unknown). On 08-FEB-2017, the patient was vaccinated with a dose of GARDASIL 9 (lot # M037770) intramuscularly in the left arm for prophylaxis. On the same day, she was also vaccinated with a dose of TENIVAC (lot number A093AJ) intramuscularly in the left arm. Concomitant therapies included dabigatran etexilate mesylate (PRADAXA).  On 08-FEB-2017, the patient experienced cramping muscles, tense muscles and muscle spasms. On 17-FEB-2017, reported as 9 days later, the patient experienced partial paralysis. On 20-FEB-2017, Magnetic Resonance Imaging (MRI) was performed and L3-4 and L5-S1 was found with active degenerative change and the patient experienced nuclear magnetic resonance imaging spinal abnormal and intervertebral disc degeneration. The outcome of the events was not reported. The relationship between the events and GARDASIL 9 and TENIVAC was not reported. The events were considered to be life threatening. Upon internal review, the event of paralysis was determined to be medically significant.     Additional information has been requested.
Three days after initial vaccination, she developed a severe occipital headache, otherwise without photophobia, phonophobia, nausea, nuchal rigidity, fever, chills, myalgias, arthralgias, or altered mental status. The headache has persisted for 1 month post-vaccination.
Fever, hives, flu-like symptoms including joint pain lasting two+ days.   Pain at injection site including entire shoulder.  Only mild symptoms with first injection.
Rash; pink indurated plaque / plaque on the patient's extremities trunk, legs and lower back; Lesions; Pink induration plaque; Pink induration plaque; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date unknown) for prophylaxis.   On 8th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced rash, skin scaly, skin lesion, skin plaque and induration. On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the skin scaly, skin lesion, skin plaque and induration were unknown.   It was unknown if the reporter considered the rash, skin scaly, skin lesion, skin plaque and induration to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right deltoid. The CMA reported on behalf the dermatologist that a patient came in their office and reported a rash that wouldn't resolve. The physician did a biopsy and it showed no danger. They completed blood work for Lyme disease and it was negative. The reporter described the rash as 1-5 cm. pink indurated plaque; some annular and scaly on the patient's extremities, trunk, legs and lower back. The multiple smooth indurated plaque and lesions were annular and others were not. The reporter consented to follow up. The reporter provided physician contact details. In the XML document outcome of event rash was reported as recovering, but in system its mentioned as not recovered, so kept as reported in system.
2 days following vax pt devel t101 & hives covering body, swelling of hands & feet, as swelling dec itching of hands & feet began; seen by MD; 2JUN94 URI developing;
I had a headache and my eyes hurt. The back of my eyes were very painful/pressure. this occurred for several days. It got less severe as time went on.  My eyes continue to be tired and I have a slight headache. there is no change in vision that I am aware. I am concerned about receiving the second COVID vaccine.
Severe headache; Fevers; nausea; body aches; severe prolonged fatigue; swollen underarms; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the second dose of BNT162B2 (lot number: EL1283 and expiry date was unknown), via an unspecified route of administration in the left arm on 10Jan2021 08:30 at single dose for Covid-19 immunization. The patient is not pregnant. Medical history included asthma. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (lot no. and expiry date were unknown) in the left arm on 21Dec2020 12:00 PM for Covid-19 immunization. The most recent COVID-19 vaccine was administered at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor any other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 10Jan2021 at 08:30 AM, the patient experienced severe headache for 12 days, nausea, body aches, severe prolonged fatigue, swollen underarms, fever for 7 days. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the events included fluids and analgesics round the clock. The patient underwent laboratory test which included Covsars2 swab/nasal swab on 13Jan2021 and the result was negative. The events recovered with sequelae.
16 hrs p/shot woke w/fever & swelling of hands & feet & face, ankles & elbows; serum sickness?
chest tightness, wheezing, anxiety, lasting 2 hours. Since this time I have noticed my tongue feels like it is burnt and sometimes numb (2 months now)
I had the shot at 8:00 a.m on 3/31.  At 4:00 the same day I broke out in what I would describe as a severe rash of hives all over my body.  it was very hot and felt like a full body sunburn.  I had the same thing again in Mid April and again on 5/13, 6/18, 6/30 and finally again today on 7/9.  Almost all rashes were the exact same.  it would feel like sunburn and after about 30 minutes to an hour, it would be gone completely.  Very weird.  I have chosen not to get the second shot as these side effects are scaring me badly.
Information has been received from a health professional concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced bronchospasm after receiving the first dose of Gardasil. No further information is available.
Information has been received from a physician concerning a female who was vaccinated with Zostavax (Oka/Merck) .65mL sub cutaneous.  Subsequently the patient developed cellulitis.  Subsequently, the patient recovered from cellulitis.  The patient sought unspecified medical attention.  There was no product quality complaint involved.  Additional information has been requested.
Pfizer 3/15/21, 4/12/21. Positive on 6/12/22
Minor + progressive body aches.  Then weakness + dyspnea.  ER visit x1 MD x3.
Patient was in store to receive the second Moderna vaccination and the pharmacist gave the J&J vaccine instead
Pt developed profound at inject site w/ chills & fever to 102.5 F occurring about 3 hrs /p vaccination. Lt arm painful /w probable cellulitis & lymphangitis at inject site. Hospitalized
severe constipation; severe pain on lower right abdomen; vomiting/inability to hold food or liquid down; blood/mucus membrane in stool; blood/mucus membrane in stool; intestinal issue; hemorrhaging cyst on ovary; severely ill; She missed period 2 days later on 06Aug2021 She got menstruation on 20Aug2021; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 04Aug2021 (Batch/Lot Number: CW0198) as DOSE 1, SINGLE (age at vaccination 40 years old) for covid-19 immunisation.  Medical history included paralyzed diaphragm from an unknown date and unknown if ongoing, skin cancer from an unknown date and unknown if ongoing, chronic inflammatory response syndrome from 16Dec2016 and ongoing. No known allergies. The patient's concomitant medications were none. Vaccination facility type: Pharmacy or drug store. Vaccine administered at military facility was no. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received the vaccine shot on 04Aug2021. She missed period 2 days later on 06Aug2021 She got menstruation on 20Aug2021.  She developed severe constipation on unknown date. On 22Aug2021, severely ill with vomiting/inability to hold food or liquid down. On unknown the patient experienced severe pain on lower right abdomen. She went to ER 2.5 weeks later with severe vomiting/abdominal pain, constipation. Hospitalized duration of stay was one day. Emergency room (ER) visit resulted in hemorrhaging cyst on ovary via ultrasound on 23Aug2021. Blood/mucus membrane in stool on unknown date, had CT scan on 03Sep2021. Determines severe constipation, intestinal issue.  "AE required visit to: Emergency room and Physician office". The patient underwent lab tests and procedures which included computerised tomogram (CT scan): severe constipation / intestinal issues on 03Sep2021, ultrasound abdomen: hemorrhaging cyst on ovary on 23Aug2021. No treatment was received. Outcome of the event she missed period 2 days later on 06Aug2021 She got menstruation on 20Aug2021 was not recovered. Outcome of the event hemorrhaging cyst on ovary, blood/mucus membrane in stool, severe constipation, intestinal issue,  severely ill, vomiting/inability to hold food or liquid down and severe pain on lower right abdomen were unknown.  It was also reported that since the vaccination, the patient had not been tested for COVID-19. The patient did not receive 2nd dose due to adverse reaction.
Approximately 3 months after my booster shot (Dose 3) I contracted COVID and had the following symptoms: High fever, Sore throat, Chills, Cough, Fatigue. I took Ibuprofen for treatment and it did not help improve my symptoms and called my doctor to ask for a prescription of the monoclonal antibody -I took it via IV medication - after a few hours I started feeling better.
pt recv 3 doses w/ no problems but failed to seroconvert;recv 4th dose & exp sore, achy muscles mostly in both upper extremities;weakness in muscles,d,n,achy joints,HA & achiness & pain in shoulder;tests nl;approx 2mo sx resolved
pt recv vax APR96 & devel an inj site rxn, characterized by redness, swelling, & tenderness;
Patient presented to clinic for influenza vaccination on 10/30/19.  Vaccine was administered on 10/30/19 at 11:49AM per PH protocol by myself (RN).  Per chart records, patient presented again to the clinic on 11/18/19 and 11/19/19 with severe right shoulder pain, and was seen by FNP.  Patient reports that the pain started soon after the vaccine was administered on 10/30/19.  NSAIDS prescribed and referral ordered.
No product quality complaints or additional adverse events were reported in this case; Patient received first dose of GARDASIL-9 at age 13. Received 2nd dose at 16 years of age; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.   On an unknown date, at the age of 13-year-old the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), as prophylaxis (formulation, concentration, route of administration, anatomical site of vaccination, lot number and expiration date were not reported), on 24-FEB-2019, at the age of 16-year-old the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), as prophylaxis, at a dose of 0.5 milliliters (ml) (formulation, concentration, route of administration and anatomical site of vaccination were not provided, lot number R025155, which has been verified to be valid, expiration date reported and validated as 23-MAY-2021) (inappropriate schedule of product administration). No adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R025155; expirationdate: 23-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
47 y/o transitioning male to female with past medical history of Asthma and Anxiety, who presents with dizziness, dry throat, nausea and nervousness post vaccination. Patient states that this is her first vaccination in the two-dose series. Patient denies previous reaction to vaccinations in the past. Patient denies sore throat, difficulty breathing, shortness of breath, itch or rash. NP and Paramedics at patient side, placed in cot and water provided. Patient states that she is taking Feminine Hormones as she is transitioning from male to female. Patient states that her hormones have caused her blood pressure to be elevated at times. Patient BP was noted to be elevated, 165/113 and all other vitals within normal limits (97% RA, 84 HR and 14 Resp). Once patient relaxed on cot for 10 minutes, she stated that the dizziness, dry throat, nausea and nervousness had resolved. Patient aware that she was not cleared for discharge due to her BPs and that we would continue to monitor her. Patient BPs ranged from 150/106, 147/104 and then 134/96. Patient monitored for 45 mins and once BPs normalized patient was cleared to be discharged home. Patient ambulated in stable condition.
Vaccine of ZOSTAVAX on 3/26/13. 3/27/13 noticed red mark on vaccine site. 3/28 swelling, redness, erythema.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 28-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 40 and 72 hours, the lowest recorded temperature was 28F (-2.222 Celsius) and the highest was 47F (8.333 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Patient stated symptoms started with little red bumps that eventually progressed to hives.  She states her skin has been very irritated and sensitive to touch.
soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th May 2018, the patient received the 1st dose of Shingrix. On 16th May 2018, 1 hr after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter indicated that after receiving Shingrix vaccine she experienced soreness at the injection site on her left arm. The soreness started approximately one hour after receiving the vaccination and resolved with one and half days. The reporter consented to follow up. The reporter gave permission for her physician to be contacted. The reporter was unable to provide any additional information. For tolerances of 2nd dose, refer case US2019074225.
The injection area became very sore and swollen , patient couldn't lift their arm Experienced, nausea, temperature fluctuations up to 102 F. , sweats, chills and crazy dreams.
Pt was in our office for well check approx 9am. pt returned to office that afternoon mom said pt conjunctival screaming since 9am visit very difficult to console, hemorrhage, it was assessed that there was no S/S hematoma right infection bilat, thighs, treatment Tylenol 0.8ml Q4D.
Elevated BP + BS on 10-7-09 thru 11-7-09. Increased urination 10-7-09 thru 10-21-09 protein 100++ no extreme fatigue. 10-7-09 to present 2 episodes of hypoglycemia 11-10-09 weakness 10-7-08. Lab studies, urinalysis, + carotid nopplin ordered.
J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 9/5/2021 COVID-19 DISEASE
mom states pt presented w/red rash w/c/o itching exp over inj site of MMR & also over entire trunk, chest & all 4 extremities;c/o sl sore throat on 11SEP95 referred to primary care provider, MD for further assessment
Blurred Vision; Falling down; Speech; Motor skills/dropping fork; Lesions on spine; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of VISION BLURRED (Blurred Vision), FALL (Falling down), SPEECH DISORDER (Speech), MOTOR DYSFUNCTION (Motor skills/dropping fork) and SPINAL DISORDER (Lesions on spine) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced VISION BLURRED (Blurred Vision) (seriousness criterion hospitalization), FALL (Falling down) (seriousness criterion hospitalization), SPEECH DISORDER (Speech) (seriousness criterion hospitalization), MOTOR DYSFUNCTION (Motor skills/dropping fork) (seriousness criterion hospitalization) and SPINAL DISORDER (Lesions on spine) (seriousness criterion hospitalization). At the time of the report, VISION BLURRED (Blurred Vision), FALL (Falling down), SPEECH DISORDER (Speech), MOTOR DYSFUNCTION (Motor skills/dropping fork) and SPINAL DISORDER (Lesions on spine) had not resolved.            Concomitant product use was not provided by the reporter. No treatment information was provided.  On 28-Apr-2021 patient received his second dose of vaccine and after 13 days he started to felt the symptoms.    No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
+ erythema, + edema, warm to touch, + signs of cellulitis. Distal from right shoulder to bicep.
12 hrs after vaccine administration reported chest pain upper retrosternal area with radiation to jaw .back with dizziness,feeling warm with chills and muscle aches  and joint pains for next 36 hrs Admitted to Hospital 7/16/21 Symptoms resolved 7/18/21 at 10 am
Pt recvd 1st dose Hep B vax 7FEB91 w/no noted problems; On 15MAR91 pt recvd 2nd dose of vax & 16MAR91 pt devel arthralgia & fatigue which MD described as serum sickness; sx persisted x several wks; 8MAY91 presented to MD office w/lethargy;
58-year-old with long history of lung disease presents with rash.  Patient received second dose of Materna Covid vaccine at 1130, at about 130 she began to feel itchy and noticed a rash to her neck which has subsequently spread to her face and upper torso. There are physical welts visible. She denies any nausea or vomiting. No sensation of swelling of mouth lips tongue or throat. No shortness of breath or change in her baseline shortness of breath. Patient did not take any medication prior to arrival. Symptoms are moderate, continuous
Deafness / Hearing was gone; ringing my left ear; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Jun2021 18:30 (Batch/Lot number was not reported) (at age of 43-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient was not pregnant. Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. No COVID prior vaccination, not tested COVID post vaccination. No known allergies. Medical history included Obese. Concomitant medications included ibuprofen; buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE); alprazolam; zolpidem tartrate (AMBIEN), all taken for an unspecified indication, start and stop date were not reported. The patient experienced deafness / hearing was gone (disability) on 26Jun2021 08:15 with outcome of unknown, ringing my left ear (disability) on 26Jun2021 08:15 with outcome of unknown. Patient stated deafness and ringing left ear that didn't go away for weeks and patient had to go to the hospital. Two days or less than two days after shot. Hearing was gone the Saturday morning. The adverse events treatment included Doctor tried nose spray, decongestants. The adverse events resulted in Emergency room/department or urgent care, Disability or permanent damage.   Information about lot/batch number has been requested.