chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt developed throat discomfort. Was given benadryl 25 mg po x1. BP 153/69, HR 65, O2sat 100%. Respirations appeared normal. Also reported arm pain radiating up to left side of face and tight chest pressure. Was given 2 puffs of albuterol inhaler. Pt stated throat felt better at this time. Repeat BP 135/59, HR 64, O2sat 99%. Pt felt shaky and cold, possibly from albuterol. Pt stated chest tightness subsided but still continued to have weird sensation in her arm up to her jaw area and throat was still feeling funny. Repeat VS 123/61, HR 61, O2sat 100%.  Was taken to ER via W/C. Pt c/o being dizzy and throat was tightening up again on the way to ER. Was given solumedrol in ER. Discharged home. Feels better but still has some left throat swelling, improved with steroids, antihistamine. Airway unaffected. Chest tightness/pressure resolved.
Patient was vaccinated on 3/30/2021 and tested positive for COVID 19 on 8/16/2021
Pt recvd 1st dose of MMR vax 1983, on 29MAY91 pt recvd 2nd MMR vax & 10minutes following vax pt fainted, eyes rolled back, limbs became rigid; hit head on steel door; sl disoriented; BP 110/70 & P100-110; exp nausea, dizziness;
Increased B/P 160/110 Pulse- 100. Resp - 28 -32 "Scratchy throat" pt felt throat was closing. Epinephrine .5mg administered at 1155A - Paramedics called immediately and 10 min response. Patient ambulance to hospital.
I went to the ER because of a fall, and a double vision, they did a lot of tests, I stayed overnight, and I was referred to a Neurologist. The doctor said I have Parkinson's disease and Myasthenia gravis, this affected my eye only.
Information has been received from a Certified Medical Assistant (Local reference number US12-040775) concerning a male patient of unknown age. On an unspecified date, the patient was vaccinated with dose 1 GARDASIL (Lot number, dose and route not reported). It was reported that the patient was admitted to the hospital for a lower extremity tingling that moved up his right leg and got worse. Approximately 30 days after vaccination with GARDASIL, the patient presented tingling left foot, went up leg, migrated to both sides, into buttocks. The patient also developed constipation and muscle weakness. Guillain Barre and neurological injury was ruled out and spinal tap was clear. At the time, the patient was getting better. Health department indicated that lumbar puncture (LP) was done too soon for west nile virus to be detected. The physician requested information in a few days. The relatedness for tingling left foot, went up leg, migrated to both sides, into buttocks, muscle weakness and constipation was unknown for GARDASIL. Additional information is not expected.
First intestinal cramping and diarrhea that lasted for 5 days, on 4th day my left arm broke out in a rash with welts, and to this date I still have bouts of my stomach aching, loose stool, and having bouts of feeling bad and then feeling better then feeling bad again.  I still feel like I have the intestinal flu.
Patient had large mottled local reaction to thigh where vaccine was administered. (R) thigh warm, red, mottling, good capillary refill below.
Information has been received from a 75 year old female consumer reporting on herself with a medical drug of ZOSTAVAX (lot # not provided) given in September 2011. On 07-MAR-2012, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# not provided). The patient said she had experienced twitching since receiving the vaccine on 07-MAR-2012. The patient said she had "female" surgery on 15-MAR-2012 and thought the twitching may be from the surgery. The patient did not receive any treatment. At the time of the report, the patient was recovering. She did not seek medical attention. The relatedness for "female" surgery and twitching were unknown for PNEUMOVAX 23. Follow up information indicated that the patient did not received the ZOSTAVAX; it was just a clerical error. Additional information has been requested.
joint pain; muscle pain; 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 ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Sep-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 16-Sep-2021, the patient experienced ARTHRALGIA (joint pain) and MYALGIA (muscle pain). At the time of the report, ARTHRALGIA (joint pain) and MYALGIA (muscle pain) outcome was unknown.            No concomitant drug information  was provided, No Treatment drug information  was provided,
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On an unknown dates, in 2014 (reported as "since October 2014") the patients were vaccinated with improperly stored GARDASIL (dose, route, lot# and expiration date were not reported). No adverse effects were reported. No PQC (product quality complaint) was reported. This is the one of several reports received from the same reporter. Additional information has been requested.
Sore arm about 6 hours after injection Achie neck and upper body muscles  after 24 hours  Fever of 99.8 after 36 hours with chills  Sweats through the night but felt much better in the morning. Probably not unusual but documented now. ;-)
BODY ACHES; DIZZINESS AND FEELING FAINT; Chills; LOW GRADE FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced dizziness and feeling faint. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, dizziness and feeling faint, chills, and low grade fever on MAR-2021. This report was non-serious.
knee pain that made it difficult to get up/wrist pain; This case was reported by a consumer via call center representative and described the occurrence of knee pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th January 2020, the patient received the 1st dose of Shingrix (intramuscular). In January 2020, less than a week after receiving Shingrix, the patient experienced knee pain. On an unknown date, the outcome of the knee pain was unknown.   It was unknown if the reporter considered the knee pain to be related to Shingrix.  Additional details were received as follows: This case was reported by patient's wife. The patient experienced knee pain that made it difficult to get up and also had left wrist pain. The reporter consented to follow up.
10:46 AM; administer Covid-19(Moderna Vaccine) 11:01 AM:  reported nausea, mild dry mouth, moderate facial numbness  11:06: Zofran 4mg po (with sip of water) x1  11:07 AM:  BP 108/80, O2 Sat = 96%, P=55 R=16 (numbness and nausea resolving) 11:25: AM: BP 120/82, P=53, 02 Sat 98%   (pt reports that she runs around all day with children so it may have counted as being athletic, she said).   11:40: Pt reported the  facial numbness resolving, nausea resolving.  Pulse  fluctuates from 50-53.  Offered to call 911, pt refused.  Pt states that she wants to go home.  If she still does not feel well she will call ambulance to go to E.R.  ( (pt reports that she runs around all day with children so it may have counted as being athletic, she said again).  11:41 AM:  Pt discharged.  normal gait and no symptoms of low Pulse displayed.   01:10 PM:  contacted pt at home.  Pt states mild increase in nausea but no numbness.  She also feels mouth dryness.  I  encouraged Pt to immediately go to E.R.  She said that she would.   1:21 PM:  contacted pt again to make sure she is going.  Pt states that she is waiting for someone to  come in and pick her up .
Patient reported waking up at 2 am on 10/20/2022 with a rash. Patient took an antihistamine before going back to bed. Upon waking, patient noticed the rash had improved. Later in the day, around 3 pm, the rash returned and was worse than when the rash presented overnight. Patient stated that about 50% of her body was covered with the rash. In addition to the rash, patient stated her eyelids were swollen and there was redness around her eyes. At the time the patient called she was still experiencing the rash and was looking for a recommendation on what to do.
I am having issues with my equilibrium/inner ear. I have difficulty with balance at times and it feels as though my left ear is clogged even though there is nothing inside of it.
1st shot. Itchy bumps on arms and hands.  2nd shot. Hives  Treatment, after 2nd shot. 24hour non drowsy antihistamine for 1 day. I still have hives. Going to take it again today.
Just after being seated in the post vaccination area, reported a headache. Describes it as a throbbing feeling over forehead area. Rates pain 3-4 on 0-10 pain scale. Patient typically only gets headache around cigar or cigarette smoke. Offered water to drink, patient accepted. By 1300, reports headache getting smaller. By 1306, headache pain 1/10 on 0-10 pain scale. Reports feeling well. Released from post vaccination area at 1306.
Vaccine given 4:20 P.M. on 5/21/14. Patient had some itchiness evening of 5/21/14. 5/22 evening became hot and red. Used ice pack evening 5/22 and 5/23 morning. Area became swollen and more red 5/23 late morning. Started really itching 5/23 12 to 12:30 PM. Pt. had Dr. visit 5/23 2:15. Dr. prescribed clindamycin and prednisone 20mg. Prednisone to be used only if red area gets larger.
had a side effect (nearly passed out); This is a spontaneous report from a Pfizer sponsored program from a non-contactable male consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had a side effect (nearly passed out) and would like to know if he should take the second covid vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PATIENT STATED THEY FELT CHILLS AND BODY ACHES ON THE FOLLOWING DAY. THE ARM THAT RECEIVED PNEUMOVAX DEVELOPED HIVES ON THE INSIDE OF THE ARM NEAR THE ARMPIT. SYMPTOMS WENT AWAY AFTER TAKING CETIRIZINE
This spontaneous report was received from a physician and from a support services director via company representative and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 21-APR-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL (lot # K023435 with an expiration date on 05-NOV-2016; dose and route of administration were not reported). The dose of the vaccine was exposed to two separate temperature excursions (dates unspecified): one lasting for 24 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.556 degrees Celsius) and the second one lasting for 48 hours, with the lowest recorded temperature of 32 Fahrenheit (0 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
c/o lt arm, unable to lift arm p/recv vax that day in lt arm;denies redness or swelling @ inj site also states felt unwell next few days, no specific sx;
Information not available.  Patient died at home.  Covid 19 listed as a cause of death on death certificate.
Patient received vaccine after published expiration date. Moderna Company analyzed lot 007B21A and advised vaccine maintained activity needed to protect  against covid 19 on date vaccine was administered.  Also patient did not call in to complain of adverse event.  This is administrative error without adverse event.
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse 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. 023H22Ab) for COVID-19 prophylaxis.     No Medical History information was reported.    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) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse 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 aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 30th of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Dec-2022: Upon internal review on 20-Jan-2023, significant correction was performed to update the Worldwide unique case identification number.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:Master case
Finger, hand and arm trembling, extreme body pain began approximately one hour after injection and continued intermittently for 6 hours the first day.  Arm tremors continued for some time the second day, and on and off for the past two weeks. Extreme muscle and body pain for the past 2 weeks, muscle twitching that subsides and returns. Since then, discussing her illness with medical providers brings on the return of the hand and arms shaking/tremors. In addition, warm water, showers lead to the hand and arm shaking/tremors as well. She saw her primary care physician on Friday April 16 who witnessed the shaking/tremors coming on. She was referred to a muscular neurologist at  hospital and seen there by Dr.  on Tuesday April 20 who also witnessed the shaking/tremors and diagnosed functional movement disorder.
breakout Herpes Simplex rash; rash; This case was reported by a consumer via call center representative and described the occurrence of herpes simplex in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number P7N2H, expiry date 30th January 2023) for prophylaxis.   The patient's past medical history included herpes simplex. Previously administered products included Shingrix with an associated reaction of herpes simplex (1st dose received on 16th July 2021, refer case US2021205534).   On 20th September 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 27th September 2021, 7 days after receiving Shingrix, the patient experienced herpes simplex and rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the herpes simplex and rash were unknown.   It was unknown if the reporter considered the herpes simplex and rash to be related to Shingrix.  Additional information was provided as follows: The reporter was the patient.  She received her 2nd shingrix dose and 7 days later developed a rash that she describes as breakout Herpes Simplex rash on her her right side. No additional information was provided. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021205534:same patient
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. The reporter stated that since May 2014 (exact date unspecified) an unknown number of patients had received doses of RECOMBIVAX HB (dosage details, route, lot# and expiration date were not reported) which underwent temperatures which fell outside the prescribing information. Among these improperly stored RECOMBIVAX HB vaccines were these that were supported and these that were not supported. No adverse events were reported. No PQC (product quality complaint) was involved. This is the one of several reports received from the same reporter. Additional information has been requested.
Patient was 10 minutes post vaccine sitting in observation area. She was talking to her friend and suddenly asked to be taken to her office. She said that she was seeing 3 of him. The friend went to the EMS personel who were staffing the event for assistance. 10:15-BP was 176/112 R arm, 10:20-167/114. Double and triple vision continued. She was put on a stretcher by EMTs. Head was elevated 45 degrees. 10:25-153/101, HR 88, still seeing "double". Began to chill and entire body was shaking profusely. Blankets were give. 10:30 AM-154/81, SaO2-99%, P-87. Husband, a retired paramedic, who had been notified, arrived. 10:35 AM-154/95, P-91 10:40 AM-156/94, 10:45 AM-158. Paremedics and nursing staff advised for patient to go to the ER or Urgent Care but she refused. 10:50-BP was 166/138, P-91. Husband insisted that he would monitor her at home. Taken to car by stretcher to go home. 9 PM, I called patient to follow up. She said that her double vision lasted for hours but finally subsided and that she had a "wicked headache". She said she did not feel like herself.
Pt. received the MCV4 vaccine on Wednesday 12-06-06 and Thursday AM Pt. had a low grade temp of 99.3. By Thursday PM he had a temp of 102. Friday he had muscle spasms in his arm, swelling of 4", and area was very warm. Friday PM Temp was 99.3 By Saturday AM all swelling was gone no further muscle spasms, and no temp.
initial LUE tingling x 1 min, then L sided scalp and facial numbness beginning 15 minutes after vaccine and lasting a few hours w/o associated other symptoms; no medical eval obtained
Fever and chills, muscle pain began after 12 hours and lasted until 72 hours after injection. Used ibuprofen to control symptoms, but was confined to bed for two days. Noticable hair loss began on day 4. I have lost about 30-40% of my hair and it is still falling out 17 days later! My scalp is now showing through my hair! Also, joint pain in my fingers began about the same time and continued for about one week. (This is no longer a problem.). My only guess is that I received the vaccine too soon after recovering from Covid-19. I was sick with Covid symptoms from June 28-July 11th
Associate received vaccine at 12:15 pm and was monitored for 15 minutes. After 15 minutes, associate went to check out table. While at check out table, associate fell to ground and was experiencing seizure like activity. Supportive treatment was administerd and associate was transferred to ED.
A couple minutes after the vaccine, it felt like left side of chest felt tight; Heart rate was high; Oxygen showed that the patient was hyperventilating; Felt hot; Anxiety; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8733) via an unspecified route of administration in the left arm on 02Apr2021 at 18:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, anxiety, acid reflux and allergy to sulfa. Concomitant medications included escitalopram oxalate (LEXAPRO), gliclazide (CLARITIN), ibuprofen (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN); all from unknown dates and for unknown indications. The patient previously the received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6208) via an unspecified route of administration in the left arm on 12Mar2021 at 18:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 18:00, a couple minutes after the vaccination, the patient experienced tightness in left side of her chest, then it was like she could felt the vaccine going through her veins and then immediately after that felt like she was hypoglycemic times 1000. It was like it affected her glucose levels. The pharmacist tried to tell her it was anxiety. The patient knew that it was 100% not anxiety. The paramedics came and also said it was anxiety and they stated oxygen showed that the patient was hyperventilating. The patient felt like her heart rate was high and she was hot and again felt hypoglycemic. But it was not the hypoglycemia that she had felt before, she did not feel like she needed to eat to take it away. They told her since the patient was not wheezing or had any sort of rash that she could leave. The patient actually sat in the car for a half hour and therapeutic measures were taken as a result of anxiety which included treatment with ATIVAN 0.5 (unspecified units) just in case and to help herself calm down. If this was anxiety, the ATIVAN would have completely taken away the symptoms. But it did not and the patient still felt "off" two hours later. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events a couple minutes after the vaccine, it felt like left side of chest felt tight, heart rate was high, oxygen showed that the patient was hyperventilating, felt hot and anxiety were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.