chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8/8/12  patient received vaccination subcutaneously in Right upper posterior arm. 8/21/12  patient phoned to report that she believes she may have had a reaction to the Zostavax. Relates the following events: 8/8/12 - several hours after the vaccination experienced injection site swelling and discomfort. 8/9/12  noted lumps under her Right arm. 8/13/12  noted throbbing pain in Right scapula area and down Right arm, she also noted red swollen papule type lumps approx. 5mm in diameter that were surrounded by a dark red area. These were not vesicles. 8/22/12  referred to company physician  noted she did not exhibit classic vesicles or crusting of HSV, prescribed Lyrica, Atarax, and Tylenol #3. Referred to her PCP for fup on 8/27/12. 8/27/12  saw PCP in fup.  Experienced swelling in face, legs, and feet which the Dr. related to the Lyrica, Lyrica was discontinued and a course of Prednisone was started and pt is using hydrocortisone cream under her arm for the itch. 8/31/12  fup appt with PCP, no further treatment.
THROBBING LEFT SIDED CHEST PAIN . FREQUENCY: ON AND OFF FOR 1 WEEK WHEN LAYING FLAT OR ON LEFT SIDE PATIENT WENT TO DOCTOR NEXT DAY AND HAD A CHECKUP.
Fever; Chills; Body aches; Sore at site of injection; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04May2021 at 16:45 (at the age of 46-years-old), as DOSE 2, SINGLE for COVID-19 immunisation. Medical history was reported as none (reported as none known). The patient had latex sensitivity. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), taken from an unknown date for an unspecified indication. The patient previously received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Apr2021 at 14:15 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05May2021 at 08:45, the patient experienced fever (100.6), chills, body aches and soreness at the site of injection. Therapeutic measures were not taken as a result of pyrexia, chills, pain, vaccination site pain. The clinical outcome of the events fever (100.6), chills, body aches and soreness at the site of injection was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: amended narrative to reflect the treatment received information for all the events as "No".
Rash developed in the middle of pts back. By days end the rash had spread across the back with some spots on shoulders and arms. No other symptoms.
Erythema, edema of left arm, elbow to shoulder. Child was irritable; unable to life arm; arm was swollen 2 X normal size by 20:00 on 3/3/01 at ER visit.
Headache, extreme malaise, chills throughout night and into following day; still experiencing continued adverse effects. Treated with fluids, rest, and ibuprofen.
Dose administered after more than 1 temperature excursion during a period of 33 weeks in 2021; Dose administered after more than 1 temperature excursion during a period of 33 weeks in 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion during a period of 33 weeks in 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursion during a period of 33 weeks in 2021) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 2:25 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 2:25 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion during a period of 33 weeks in 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursion during a period of 33 weeks in 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion during a period of 33 weeks in 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursion during a period of 33 weeks in 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   An age of patient was reported as 72.13.  No concomitant medications were reported. It was reported that for the vial Batch number of 025L20A, it was moved to fridge on 05-Jan-2021 that underwent temperature excursion on 07-Jan-2021 with temperature 34 degrees Fahrenheit from 09 AM to 10 AM. The product was moved to clinic on 07-Jan-2021 and beyond use date for the vial was reported as 27-Jan-2021.  The vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. The vials were only punctured right before administration. The vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
On 04/19, pt woke up with itchy rash on arms, legs and back. No fever, no headache or other neurological complaints. Rash progressively got worse. On 04/23, went to pediatrician. Mother states the pt was treated for scabies but he continues to itch as of 04/24.
Pt recv vax on 12/2/98; on 12/4/98 pt exp red & swelling (of vax site??), wheezing, fever (101.2), cough & rattle; tx=Tylenol & Benadryl
APPROXIMATELY 2 MINUTES AFTER RECEIVING IMMUNIZATION PT BE CAME WEAK AND DIZZY.  ACCORDING TO FATHER PT "SLUMPED OVER AND JERKED A FEW TIMES".  PT NOTED TO BE VERY PALE.
At 0632 patient woke up to go to the bathroom, felt dizzy, and fainted on the floor face down. I  awoke from the noise and found him trying to stand up. At about 0634 patient fainted again. I brought him to lay down on his back on the floor. No seizure-like activity or loss of consciousness. Pulse was thready but resolved after about 5 minutes. Had patient lay on back and elevate lower extremities. Patient felt chilly and fever-ish, but was not able to get reliable temperature at this time.
I had an outbreak in shingles and ended up at the hospital because of dehydration and on the way to the hospital I broke out in a rash that was the size of a dime. I was nausea, had headaches, body aches. I went to ER when she became dehydrated and nausea.
APPROXIMATELY 40 HOURS AFTER RECEIVING VACCINE,I EXPERIENCED VIOLENT DIARREA AND VOMITING. 1 MONTH LATER, I EXPERIENCED LOW-FREQUENCY EXPIRATORY WHEEZES, COUGHING, FURTHER CONGESTION IN NOSE AND CHEST. PREDNISONE TAPERED DOSAGE ADMINISTERD. AFTER FOUR DAYS, I AM BETTER.
I had taken some Tylenol due to a high fever after having the booster the day before (102.9) and went to sleep about 1 pm. I woke up about 3 pm and noted that my face felt like it was numb or asleep. The sensation started below my eyes on both sides of my face, extended down to what would be maybe below my upper lip, and also included my upper lip but not my nose. My face was somewhat flushed, but I assumed that was from the fevers I had been managing since 3 am. My face was not swollen, my tongue was normal in size and color and was not involved, and I had no difficulty breathing, swallowing, seeing, smelling, etc.
Janssen COVID-19 Vaccine EUA. Severe headache in the night of Vaccine followed by vomiting. Sleepiness and disorientation the next two days.  Hospital ER   and discovery of bleeding in the brain and admission to the NICU
fever of 101 8/30/99 around 7PM-830PM; following day 8/31/99 @ the office initial T105 R; p/a minute temp taken again 104R;
PT FAINTED 5 MIN INTO THE 15 MIN OBSERVATION PERIOD AND  REGAINED CONCIOUSNESS . PT WAS TAKEN BY EMS TO BE EVALUATED. PT FATHER CALLED PHARMACY BACK AND SAID ALL TEST WERE NORMAL AND THE DIAGNOSIS WAS SYNCOPE.
Pt called BOH following day of vaccine administration. States left arm swollen and red, asked to come to BOH to check area. Pt left arm large amount of redness, swelling from shoulder to elbow, tennis ball size are hot, hard and swollen at elbow area (bracheal artery). Instructed to see MD today. Pt seen by MD 1 hour RID. MD states severe allergic reaction, on Prednisone taper for 7 days.
Pfizer-BioNTech COVID-19 Vaccine EUA  ~30 minutes post injection developed bilateral visual disturbance best described as an aura (shiny waves) in my inferior visual fields. No associated migraine/HA, photophobia, N/V, etc. This lasted for ~ 2 hours, did NOT hinder my day-to-day activities that day.
4 x 5" red, warm, indurated, tender mass RUE.  No fever, hurts to move arms, developed 24 hours after injection.
Initial unsolicited report received from a consumer on 12-JUL-2017. This case involves a 23-year-old male patient (age also reported as 24 years) who was vaccinated with an intramuscular dose of IMOVAX in left deltoid and a dose of PASTEURIZED HUMAN RABIES IMMUNOGLOBULIN (IMOGAM) site of administration were not reported (for both the vaccines batch number, expiry date, dose, dose in series were not reported) on 11-JUL-2017. The patient had a medical history of ulcerative colitis, primary sclerosing cholangitis and asthma. It was also reported that the patient did not had any Illness at time of vaccination. Concomitant medications was not reported. On 11-JUL-2017, few hours following the vaccination, the patient experienced numbness in all extremities (also reported as less than 24 hours after receiving vaccine), fever and muscle pain. No lab test was performed. Corrective treatment was not reported. The patient had not recovered from the events. Follow up information received from a consumer on 12-JUL-2017. Lot number for Imovax updated as M13911M and lot number for Imogam was not available. List of documents held by sender: none.
Fever, joint pain, headache, chills. Treated with Tylenol. Lasted for approx. 19 hours.
went to ER 24OCT92 w/rigors & chills; seen by MD who adv it was reaction to flu vax; no tx doing well now;
Itching started  at late night 8 days  after my second shot.I don?t remember any itching after my first shot.. itching started behind  left ear, to head and left forehead, to upper chest and then to inside of upper thighs . Raised flat red itchy, started taking Pepsid , Zyrtec  and benedryl  that afternoon Nd evening, mostly gone I the next day nd. O itching or rah after that, still on the drugs but will try to cut back and see what happens.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant mediations provided. On 19-JUN-2015, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX (route subcutaneous, dose was not reported, lot # reported as L004652, expiration date 11-FEB-2017) that was improperly stored. There was no adverse effect reported. Additional information has been requested.
Within 15 minutes after the vaccine patient started to have tachycardia, dizziness, and light headedness with syncope episode.  She was taken to the ER where she improved .  No further syncope episodes and released.
Post covid vaccine administration, while sitting for 10 minute time frame, complained of numbness and tingling in mouth and tongue. States she is allergic to apples and avacodos and this is the type of reaction she normally has after eating this type of food. Patient evaluated by facilitator. No difficulty breathing or shortness of breath noted, patient not in distress. Numbness and tinging continued past 10 minutes observation time not improving. ERT called to evaluate patient. No distress noted. Taken to pharmacy and received oral diphenhydramine. Sitting in clinic for additional time frame - total approximately 70 minutes post vaccine. Complaints of feeling some nausea. No distress again noted. Continues to complain of tingling and numbness in mouth and tongue at 1800 which is approximately 40 minutes post medication. Additionally complaints of feeling more numbness around mouth. VS taken: T - 37.1, P - 68, BP - 128/80, R- 18, pulse ox - 100%. No difficulty breathing. States situation unchanged from previous. ERT notified again. Patient evaluated by team. Options discussed with patient by team nurse - can be seen in ED or go home and take additional dose of antihistamine in 4 hrs from time of first dose. Encouraged to get a ride home and leave car at hospital. Husband called by patient. Waiting for ride. Encouraged to seek additional medical care if not feeling improved after 2nd dose of medication at home. Also encouraged to discuss 2nd vaccine dose with PCP prior to taking 2nd dose. Discussed with patient to utilize vaccine app to document post vaccine effects. Escorted to hospital lobby for ride at 1830.
suspected covid-19; next day I had a little bit of body ache, and then today a little bit more; also a little bit of a scratchy throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SARS-COV-2 ANTIBODY TEST POSITIVE (medically significant), outcome "unknown" and all described as "I took an antibody test and it came out positive"; PAIN (non-serious) with onset 28Dec2021, outcome "unknown", described as "next day I had a little bit of body ache, and then today a little bit more"; THROAT IRRITATION (non-serious) with onset 28Dec2021, outcome "unknown", described as "also a little bit of a scratchy throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Additional information: onset latency for the events was 01 day.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Tingling of the legs; Breath Soreness; Extreme dehydration; Elevated C-reactive Protein; Burning sensation; Joints hurt - Knee Worse; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Tingling of the legs), DYSPNOEA (Breath Soreness), DEHYDRATION (Extreme dehydration), C-REACTIVE PROTEIN INCREASED (Elevated C-reactive Protein) and BURNING SENSATION (Burning sensation) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was 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 PARAESTHESIA (Tingling of the legs), DYSPNOEA (Breath Soreness), DEHYDRATION (Extreme dehydration), C-REACTIVE PROTEIN INCREASED (Elevated C-reactive Protein), BURNING SENSATION (Burning sensation) and ARTHRALGIA (Joints hurt - Knee Worse). At the time of the report, PARAESTHESIA (Tingling of the legs), DYSPNOEA (Breath Soreness), DEHYDRATION (Extreme dehydration), C-REACTIVE PROTEIN INCREASED (Elevated C-reactive Protein), BURNING SENSATION (Burning sensation) and ARTHRALGIA (Joints hurt - Knee Worse) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-214406 (Patient Link).
chills and achey; low blood sugar, shaking not feeling good; low blood sugar, shaking not feeling good; Shaking; chills and achey; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE DECREASED (low blood sugar, shaking not feeling good), MALAISE (low blood sugar, shaking not feeling good), TREMOR (Shaking), PAIN (chills and achey) and CHILLS (chills and achey) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included PARACETAMOL (TYLENOL), PROBIOTICS NOS, MULTIVITAMIN [VITAMINS NOS], COLECALCIFEROL (D3), CALCIUM, BRIOBACEPT (BRIO), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), SEMAGLUTIDE (OZEMPIC), EMPAGLIFLOZIN (JARDIANCE), IRBESARTAN, INSULIN, INSULIN LISPRO (HUMALOG), INSULIN GLARGINE (BASAGLAR), TORSEMIDE and POTASSIUM CHLORIDE for an unknown indication.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (chills and achey). On 09-Mar-2021, the patient experienced BLOOD GLUCOSE DECREASED (low blood sugar, shaking not feeling good), MALAISE (low blood sugar, shaking not feeling good) and TREMOR (Shaking). On 10-Mar-2021, the patient experienced PAIN (chills and achey). On 05-Mar-2021, CHILLS (chills and achey) outcome was unknown. At the time of the report, BLOOD GLUCOSE DECREASED (low blood sugar, shaking not feeling good), MALAISE (low blood sugar, shaking not feeling good), TREMOR (Shaking) and PAIN (chills and achey) outcome was unknown.            Concomitant medications included Pepcid, Nexium, Digestive Enzymes and Centrum silver. Patient took two Tylenol for treatment.   Reporter did not allow further contact
Fever, aches and joint pain, headache, diarrhea, vomiting  - for 2-3 days, general malaise - 1 week.
5-6 hrs after the vaccine (that evening) patient noted a "light, smooth" faint rash on stomach & back (from shoulders to hips), no itching, no hot, no other symptoms.  Resolved by morning.  Pt didn't come in to be seen by provider.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX (received a couple of years ago). On 28th April 2018 11:48, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a day after receiving SHINGRIX, the patient experienced stomach cramps, shivers and erythema of extremities. On 28th April 2018, the patient experienced pain in arm and injection site pain. In April 2018, the outcome of the stomach cramps was recovered/resolved. On 29th April 2018, the outcome of the shivers was recovered/resolved. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the erythema of extremities was unknown and the outcome of the injection site pain was recovered/resolved. The reporter considered the pain in arm, stomach cramps, shivers, erythema of extremities and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The site of injection of the vaccination hurt during the injection of the product and her left arm was a little sore that day. In the night after receiving the vaccine, the patient experienced shivers and stomach cramps. The stomach cramps resolved within a couple of hours and the shivers resolved by the next morning. Progressively, since the vaccination was administered the patient's arm had become more sore and redness began to develop that extends six inches down her arm. Less than a week after vaccination, the patient experienced redness. The redness spread approximately one inch from 30th April 2018 to 1st May 2018. The patient's arm was not as sore as it was on 30th April 2018. The patient had denied permission to contact their physician. The reporter did not currently have a physician as she has just moved to the area. The reporter was unable to provide additional information.
Itchy rash/hives on both forearms away from the injection site; Itchy rash/hives on both forearms away from the injection site; Itchy watery eyes; Itchy watery eyes; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration, in the left arm, on 17Mar2021 at 14:00 (at the age of 46-years-old) at dose 1 single dose for COVID-19 immunization. Medical history included asthma. No known allergies were reported for the patient. Concomitant medications included effexor (VENLAFAXINE HYDROCHLORIDE), wellbutrin (BUPROPION HYDROCHLORIDE), lisinopril and plexus (AMBROXOL HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE). The patient did not receive any other vaccines four weeks prior to COVID-19 vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination. On 19Mar2021, the patient had itchy rash, hives on both forearms away from the injection site and had itchy watery eyes. The events did not result in doctor or other healthcare professional office or clinic visit, or emergency room visit. The patient did not receive any treatment for the events. The clinical outcome of the events was 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.
41 days after the Janssen COVID-19 vaccine, pt developed a R thoracic neuritis, still present to this day, painful, wraps around in a shingles-like distribution but did not have shingles.  Later also developed a L thoracic neuritis, similar to R.  Still present and painful to this day.
Patient received vaccinations at approx 10:50 am.  PHN instructed her to remain sitting in her chair after receiving her vaccines.  She sat in the chair for approx 5-7 min, then patient and her mom left the nurse's office and walked out to the HD main lobby to schedule the next clinic appt.  They were in the lobby for approx 1-2 min. when PHN heard a "thud" and the admin asst shouted for PHN to come to the lobby.  PHN grabbed an ammonia inhalant and ran to the lobby.  PHN arrived in the lobby within 30 seconds of admin asst shouting for PHN.  Patient was laying face up on the floor in the HD lobby doorway.  Patient was responsive when PHN knelt beside her.  PHN Instructed her to remain laying down.  She was crying and upset and sat up.  PHN knelt behind her and supported her in the sitting position.  PHN waved the ammonia inhalant under her nose and told her to remain sitting.  Patient stated her head hurt, and wasn't sure what happened.  Patient's mom stated that patient was standing at the admn asst desk in the HD lobby and passed out and fell into the health dept entry way and hit her head on the floor of the building lobby.  PHN applied an icepack to the back of patient's head.  Another HD staff member called 911. HD police chief and HD fire capt. arrived on scene.  HD fire capt took over care of patient until FD EMS arrived.  FD asked mom if they wanted them to transport patient to the hospital.  Mom stated she would like her to be transported to hospital.  Transport to hospital by FD occurred at approx 1130-1145 am.  PHN followed up with mom on 11/6/19 at approx 2:30 pm.  Mom stated patient was home and resting. Mom stated that patient did not have a concussion, no CT scan was done.