chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported burning sensation at end of injection to her husband.  She asked her husband if he had experienced the same thing.  After saying no, he reported her reaction to the pharmacist (me).  I asked her if she was still have a burning sensation and she said no. It only occurred at the end of the injection.
Pt was in the store for observation post vaccine.  About 10 minutes after the shot, she came back to the pharmacy and reported she was not feeling right.  She was extremely tired, weak, and dizzy.  She was told to sit down for further observation and given a bottle of water.  About 5 minutes later, she said she was still feeling really bad.  She said she was not thinking clearly and didn't feel right. She was also experiencing moderate pain down her spine.  She said her thinking was so affected that she wanted to seek treatment.   Patient declined offer to call EMS, and proceeded to an urgent care clinic next door.  Urgent care later called the pharmacy to inform us that patient had been transported to the hospital by ambulance.
from 1201 am to 0515 am on 1/7/21--headache, neck pain, cold hands/feet, chills, nausea, low grade fever (99 degrees)  treatment taken at 0515 am --1 dramamine, 2 tylenol 0800 am- headache, temp 98.3 0915 am- headache treatment- 1 advil pm 0815 pm- temp 99, chills treatment- tylenol  3 days post vaccine- headache, nausea  (treatment advil pm, dramamine) 6 days post vaccine- headache, nausea (treatment advil pm, dramamine) 9 days post vaccine--headache, nausea (treatment advil pm, dramamine)
Started with a fever of 101 and lead into the next day. By 9/16/2012, woke up in AM with little red bumps on chest, back and neck and progressed throughout the day. By 9/17/2012, with rash had spread to face, arms, lower torso, and legs. Started experiencing itching and uncomfortable appearance by this time. He rash appears to be significate and covers most of the torso and face.
THU Day 1. First Shot: About 20 minutes after the injection, I felt like I had received a muscle relaxer. Instant tired. Went to sleep. FRI Day 2. Injection site pain 7/10. Arm mobility severely limited. General muscle and joint aches 6/10 pain. No fever, but felt hot. Still feel hot, with no fever, on Tue Day 6 (which is today). Fatigue 7/10. Persistent feeling of hunger for about 3 days, no matter how much I eat. SAT/SUN/MON. Regained full use of my left arm. Still feel exhausted 5/10. Head, neck and shoulder pains 8/10.  Still feel like I have a fever, but no fever. Persistent runny nose for four days and sore throat 3/10 pain. The oddest thing is that I have an occasional ringing in my ears. Mostly my right ear. A constant static-hissing sound, sometimes a full ringing that fades back to a static-hissing. Very odd. TUE Day 6. Feel hot in the head, no fever. Hearing  hissing-static/ringing sound on and off. Runny nose, sore throat. Just wanted to share so you can collect more data.
Rash with raised bumps on chest, left breast, back of left arm and upper back.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 19Mar2021 at 09:45 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. Medical history included lung disease, rheumatoid arthritis and lupus. The patient was allergic to Z-pak. Concomitant medications included mycophenolate (MANUFACTURER UNKNOWN), prednisone (MANUFACTURER UNKNOWN), PLAQUENIL, sulfamethoxazole (MANUFACTURER UNKNOWN), ACTON; all for unknown indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021, the patient experienced rash with raised bumps on chest, left breast, back of left arm and upper back. The rash does not itch. The rash was very tender to the touch. The patient did not receive any treatment for the reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events rash with raised bumps on chest, left breast, back of left arm and upper back was not resolved.  No follow-up attempts are needed. No further information is expected.
Muscle ache in both power legs. Bottom and top of right foot extremely painful to walk.  Bottom left side of left foot extremely painful.  Calves muscles on right leg extremely tight.  Top of right foot extremely tight and painful.
Severe sleepiness, nausea, fever, chills, red lines appearing at site of injection, soreness and pain at sight of injection
Rash started a few hours after vaccine, worsened before 24 hours post vaccine. No fever or respiratory difficulties. No other symptoms.
On 11/11/04 patient called to report acute episode of bleeding in nose and gums which resolved without treatment. Over next 24-48 hours had fever 100.5 self treated with Tylenol and muscle aches/pain, chilling, nasal congestion and diarrhea x 3 episodes: Treated with Immodium. Symptoms resolved over 5 days.
This spontaneous report as received from a licensed practical nurse refers to a 19 year old female patient. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. In July 2016, the patient was vaccinated with GARDASIL 9 (dose 1, dose, route and lot # not reported) for prophylaxis. The series of GARDASIL 9 should be completed by July 2017. But on 27-JUL-2017, the patient was in the office to receive the second dose of GARDASIL 9 (lot # N013695, expiration date 21-MAR-2019) (inappropriate schedule of vaccine administered). No adverse effects reported.
Approximately 1.5 hours after receiving the vaccine, she noticed redness on her arms, upper chest and back of her neck which was mildly itchy and burning. She took Benedryl 25 mg prior to the vaccine and 25 mg after the symptoms appeared. Symptoms resolved within about 24 hours.
Swelling of the arm; Excruciating pain/extreme pain/woke up crying in pain/woke up screaming in pain/The pain was 9 out of 10 points.; She was very afraid; Entire armpit area was swelling; Extremely painful chest pain; It was so uncomfortable; Gained some weight; Swelling of her lymph nodes under the armpit; Entire armpit area was painful; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of the arm), PAIN (Excruciating pain/extreme pain/woke up crying in pain/woke up screaming in pain/The pain was 9 out of 10 points.), ANXIETY (She was very afraid), SWELLING (Entire armpit area was swelling) and CHEST PAIN (Extremely painful chest pain) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 006C21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Herniated disc and Penicillin allergy. Concomitant products included BUPRENORPHINE HYDROCHLORIDE (BELBUCA) for Herniated disc, MULTIVITAMINS [VITAMINS NOS], COLECALCIFEROL (VITAMIN D3), VITAMIN B2 [RIBOFLAVIN], ZINC and PARACETAMOL (ACETAMINOPHEN) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling of the arm), PAIN (Excruciating pain/extreme pain/woke up crying in pain/woke up screaming in pain/The pain was 9 out of 10 points.), ANXIETY (She was very afraid), SWELLING (Entire armpit area was swelling), CHEST PAIN (Extremely painful chest pain), FEELING ABNORMAL (It was so uncomfortable), WEIGHT INCREASED (Gained some weight), LYMPHADENOPATHY (Swelling of her lymph nodes under the armpit) and AXILLARY PAIN (Entire armpit area was painful). At the time of the report, PERIPHERAL SWELLING (Swelling of the arm), PAIN (Excruciating pain/extreme pain/woke up crying in pain/woke up screaming in pain/The pain was 9 out of 10 points.), ANXIETY (She was very afraid), SWELLING (Entire armpit area was swelling), CHEST PAIN (Extremely painful chest pain), FEELING ABNORMAL (It was so uncomfortable), WEIGHT INCREASED (Gained some weight), LYMPHADENOPATHY (Swelling of her lymph nodes under the armpit) and AXILLARY PAIN (Entire armpit area was painful) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, HLA-B*27 assay: positive (Positive) Positive for HLA B27 Antigen.         Other concomitant medications included Soloxide, unspecified anti inflammatory and birth control medications. No treatment medications were reported.   This case was linked to MOD-2022-551334 (Patient Link).
Large red, raised area at the injection site approximately 2 inches around where needle was injected into arm.  Donor states it was itchy, no other s/s.  Placed warm wash cloth over site.   3/26/22 - Donor states itching stopped 24 hours after injection.   3/27/22 - Swelling has decreased, but still some redness noted today.
3 days after patient received first dose she was dehydrated due to nausea and vomiting, she had chest pain and chills.  She went to hospital 1 week later and they gave her IV fluids  and sent her home. Blood Pressure was elevated but no treatment administered.
Three days after vaccine administration patient states they experienced soreness on the right leg. On April 28 (8 day after vaccination) patient began to experience swelling in the right foot/leg in addition to the soreness. This continued till Saturday 4/30. Patient saw podiatrist on 5/2/22 and provider recommending massaging the area. Patient states that they are still experiencing soreness.
Pt had eyelid and face swelling. Patient was directed by their doctor to take benadryl and symptoms resolved. The COVID 19 is the current Comirnaty product that was just released. Patient had no reactions with all previous doses of the Pfizer COVID 19 vaccine.
Two days after my second-dose injection, I reacted with a large, red and slightly-raised patch of skin around injection site that was hot and very sensitive to touch. Also, painful swollen lymph nodes in left armpit.  It is now the 5th day after my injection and the redness and pain around injection site has decreased, but now itches. Swollen lymph nodes in armpit are beginning to shrink, but are still tender.
26JUL91 PT recd vax for routine prophylaxis; 26JUL91 PT developed sore throat & became very dizzy; reporter indicated events were "potentially" immediately life threatening; no rx given; events resolved "on their own";
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2011, the patient was inoculated with ZOSTAVAX by a physician for routine health maintenance and prevention of shingles (prophylaxis) (strength, dose, route of administration, lot # and expiry date was not reported). On an unknown date, the patient was diagnosed with shingles (herpes zoster) despite of vaccinating with ZOSTAVAX (vaccination failure). On an unknown date in June 2016, the patient was treated for shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
High blood pressure & heart rate (202/100 & 100), ear ache, chills and fever, fatigue.
Patient called clinic 5 days post-vaccination to report that the entirety of the ulnar side of his left hand is numb, including the small and ring fingers. He says that this occurred "immediately" after receiving the vaccination but he did not mention it at that time because he had to leave to pick up one of his children from school.
lethargic; sleeping a lot; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), HYPERSOMNIA (sleeping a lot), HEADACHE (headache) and NAUSEA (nausea) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-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) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced LETHARGY (lethargic), HYPERSOMNIA (sleeping a lot), HEADACHE (headache) and NAUSEA (nausea). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) at an unspecified dose and frequency. At the time of the report, LETHARGY (lethargic), HYPERSOMNIA (sleeping a lot), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.
7AM on 2JUL97 pt became sick to stomach, vomiting, fever of 100;took advil threw that up;heart racing, felt like it was pounding in chest;took pulse 72 & 74;mild h/a;called MD told it was most likely rxn to shot;feeling better by 3PM;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 14-NOV-2014, the patient's healthcare provider administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 17-AUG-2017, the patient was treated by his healthcare provider at a clinic for shingles.  The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a child who on 27-May-2003 was vaccinated with a dose of varicella virus vaccine live. On 28-May-2003, the patient's sibling developed varicella. Unspecified medical attention was sough. There was no product quality complaint involved. Additional information has been requested.
Easy bruising beginning on 1/13/14 and resolving around 1/17/14; No treatment.
Case number PHEH2014US026188, is an initial spontaneous report from a pharmacist received on 31 Dec 2014 and with a follow up information received from the pharmacist on 03 Feb 2015. This report refers to a 52-year-old female patient. Medical history and concomitant medications were not reported. Her vaccination history included vaccination with Tdap (unknown manufacturer, batch number: not reported) on unspecified date about 03 years ago. She was vaccinated with FLUVIRIN (batch number: 145403) intramuscularly in the right arm at a dose of 0.5 ml on 31 Dec 2014 at 11.00 AM. On the same day, after vaccination, the patient experienced swelling at the injection site around 1 inch in diameter. The outcome of the event was reported as complete recovery. Seriousness and causality of the event was not reported. Follow up information received from a pharmacist on 03 Feb 2015: Updated vaccination history (Tdap), site, dose and time of vaccination of FLUVIRIN and outcome of the events (complete recovery).
unconscious; seizure; throwing up while unconscious; This is a spontaneous report from a contactable other healthcare professional (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Ew0169), dose 1 intramuscular, administered in Arm Right on 13Apr2021 14:45 (at the age of 23years) as single dose for Covid-19 immunization. The patient is not pregnant at the time of vaccination. There were no medical history and concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on 14Apr2021 (10:15 PM), the patient was unconscious for about 15 seconds, having a seizure for 5 seconds, and throwing up while unconscious. The adverse events resulted in Emergency room/department or urgent care. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovering.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events loss of consciousness, seizure, vomiting and the suspect vaccine BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No other medications in 2 weeks. Patient received COVID 19 treatment with Paxlovid from 19May2023 to 26May2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender who on 11-AUG-2014, was vaccinated with GARDASIL, 0.5ml, intramuscular. The healthcare worker, reported that GARDASIL that underwent a temperature excursion has been administered. No adverse effect reported. No further information was provided. The outcome of GARDASIL that underwent a temperature excursion has been administered was unknown. The reporter considered incorrect storage to be not related to GARDASIL. This is one of several reports from same source. Additional information has been requested.
Extreme. Pain in arm spreading in to neck resulting in screaming agony. Feeling of ropes wrapped around muscles under skin and gripping and pulling taught. Large red welts forming in areas around right arm but not at the injection site directly
29 year old male had possible high risk rabies exposure received RABIVERT in deltoid. Fifteen minutes later generalized facial swelling, no airway obstruction resolved with BENADRYL.
THE PATIENTS WIFE CONTACTED THE PHARMACY VIA TELEPHONE AND STATED THE PATIENT IS EXPERIENCING A RASH AT THE INJECTION SITE. THE RASH IS COVERING HIS LOWER SHOULDER AND UPPER ARM. THE PATIENT IS NOT EXPERIENCING SWELLING OR RASH ON NECK, MOUTH , FACE OR THROAT. THE PATIENT IS NOT HAVING DIFFICULTY BREATHING.
Patient came in with a consent form and Covid card and said she is getting Moderna. Covid Card Said Moderna so we looked at the consent and put the lot and vaccine received on card and consent form. The check in person checked the age based on the year, put Moderna and lot on the consent form so she went the vaccinator to receive the vaccine. Vaccinator asked patient what she received before and looked at everything to verify patient received Moderna before. Either the previous place where patient received the vaccine reported it wrong or the card is wrong. We spoke to mother to inform her what happened and she is aware patient is eligible to get booster in 5 months for Pfizer. Mother was confused because child also told her the first time she got the first dose of Covid vaccine she received Moderna as well. Patient was monitored for 15 minutes after receiving the vaccine. Patient was doing okay and mother is aware.
Soreness, bump showed up, spreading from arm to shoulder, numb, tingles at times. Lasting for several weeks.
Muscle and shoulder pain that got worse with each passing day. Limited range of motion in shoulder. Still experiencing to this day and concerned that this will not go away.
No adverse events - No treatment needed. *Child was given "ZOSTAVAX" instead of "PROQUAD".
pt exp worsening weakness x 2mo w/diff walking x2wk;pt exp joint stiffness;devel some numbness in hands & feet;pt noted to have flipped T waves in lateral chest leads;pt hosp;muscle weakness;GBS, ataxic;control dec;polyradiculoneuropathy;
No other AE reported; PROQUAD that expired 03/02/2021 was administered yesterday, 03/25/2021 to a 5-year-old; This spontaneous report has been received from a medical assistant referring to a 5 years old patient of unknown gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 25-MAR-2021 (also reported as yesterday), the patient was vaccinated with an expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S027463 has been verified to be a valid lot number, expiration date: 02-MAR-2021; 0.5 ml) via unknown route for prophylaxis (expired product administered). No product to retrieve. No other adverse event (AE) reported.