chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe body aches, extreme pain; Bad headaches/ severe headaches; Dizziness; Chills; Muscle spasm; Nausea; I had to call off work; This non-serious case was reported by a consumer and described the occurrence of general body pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included trouble falling asleep. Concomitant products included zolpidem. Family history included guillain barre syndrome (grandmother became incapacitated when she got the swine flu in 70s.).   On 12-APR-2023, the patient received Shingrix. On 12-APR-2023, less than a day after receiving Shingrix, the patient experienced general body pain (Verbatim: Severe body aches, extreme pain) and headache (Verbatim: Bad headaches/ severe headaches). In APR-2023, the patient experienced dizziness (Verbatim: Dizziness), chills (Verbatim: Chills), muscle spasm (Verbatim: Muscle spasm), nausea (Verbatim: Nausea) and impaired work ability (Verbatim: I had to call off work). The outcome of the general body pain and headache were not resolved and the outcome of the dizziness, chills, muscle spasm, nausea and impaired work ability were not reported.   It was unknown if the reporter considered the general body pain, headache, dizziness, chills, muscle spasm, nausea and impaired work ability to be related to Shingrix.     It was unknown if the company considered the general body pain, headache, dizziness, chills, muscle spasm, nausea and impaired work ability to be related to Shingrix.   Additional Information: GSK receipt date:13-APR-2023 This case was submitted by the online direct entry reporting system.  This report was submitted by site: Public Reporting Selected. The patient was the reporter. The reporter's grandmother had guille barre syndrome and became incapacitated when she got the swine flu shot in the 70's. (Severe body aches, bad headaches )  The symptoms were not treated. The reporter consented to follow up.
Vaccine administered at 2pm. Pt. reported waking up from sleep at 0130am - both eyes itching and slightly puffy lids - more so on the left eye. She self-administered OTC allergy eye gtts. Puffy lids noted at work at 0800AM (No other symptoms). Subsided completely by 12 noon same day.
1st injection, patient felt what she thought was the needle hitting her bone. 2 days later, deep pain, no skin reaction. Sore at injection site. Pain lasted about 2 weeks. 2nd injection, pain worse, and has continued with progressive swelling of anterior upper arm and shoulder.  Swelling is tender, not hot, feels firm, no evidence of fluid.  This has continued from February until now, Aug. 28, 2021.  Pain has gotten so bad it is interfering with sleep.  Would a course of prednisone help?  Your questionsire does not fit our problem.  This was not an acute obvious allergic reaction.  I am her husband, and a retired M.D. (pediatrician).  We need your advice and help. Thanks.
Patient received their Pfizer Covid-19 Booster under the 6 months required. The patient received their second dose on 6/10/21 and then their booster on 11/22/21. No adverse reaction reported.
Tested COVID-19 + on 4/27/21. Was tested due to recent high-risk exposure any mild cold-like symptoms. Had Pfizer COVID-19 vaccines on 12/31/2020 and 01/21/21.
Constant, muscle tightness, stiffness weakness of leg and back muscles.  Sacroiliac pain, tightness bordering  on the unbearable.
Back pain; Mobility issues; Sore arm after all covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), MOBILITY DECREASED (Mobility issues) and VACCINATION SITE PAIN (Sore arm after all covid vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Solution for injection in pre-filled pen. On an unknown date, the patient experienced BACK PAIN (Back pain), MOBILITY DECREASED (Mobility issues) and VACCINATION SITE PAIN (Sore arm after all covid vaccine). At the time of the report, BACK PAIN (Back pain), MOBILITY DECREASED (Mobility issues) and VACCINATION SITE PAIN (Sore arm after all covid vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Magnetic resonance imaging: bone spurs.         Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  On 29-Mar-2021, the patient experienced bone spurs. It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.   This case was linked to US-MODERNATX, INC.-MOD-2022-622380 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-622380:Dose 2
Patient notified office of muscle pain and weakness in arm injection was given; Recommended warm compresses and OTC Aleve; pt instructed to call if symptoms worsen or no improvement.  Patient contacted office on 6/22/16 reporting same symptoms. Patient was seen in office and prescribed Prednisone 20mg, 2 PO twice daily for 5 days.
A few minutes after being vaccinated patient was sitting for her 15 minute observation period and walked over to the pharmacy counter stating "I just got my vaccine and I really don't feel well" the pharmacist approached the patient and caught her under both arms from behind her back as the patient fainted.  Patient did not hit the ground or injure herself-she did not lose consciousness she was flushed and sweating.  Pharmacist sat on floor with patient for 2-3 minutes and gave her water, patient was then able to stand up with little assistance and brought to sit down.  Patient stated she felt nauseous and may vomit she was given a trash can but did not vomit she was able to drink a bottle of water and was given a soft pretzel.  After about 10 minutes she stated she was feeling much better was no longer flushed or sweating she called her boyfriend for a  ride home.
This case was reported by a nurse via sales rep and described the occurrence of shortness of breath in a adult male patient who received Shingrix (batch number 957J3, expiry date 15th November 2020) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced shortness of breath, chest tightness and anxiety. On an unknown date, the outcome of the shortness of breath, chest tightness and anxiety were unknown.  The reporter considered the shortness of breath, chest tightness and anxiety to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced  shortness of breath day after admininstration of Shingrix, chest tightness, could not get a full breathe of air, and anxiety all attributed to Shingrix. The nurse agreed to be contacted for follow up.
Migraine (2 days after) from day 3- still going on, chest congestion, coughing up thick light green to dark green chunks, nose congestion, weakness/tiredness, sore throat, dyrehia
D68.9 COAGULOPATHY, UNSPECIFIED TYPE 6/6/2023 MELENA
My dad has been experiencing what seem to be definite blood clot symptoms since the vaccine but he refuses to go to the dr. Shortly after the vaccine he experiencing stabbing headaches that came on quickly and went away in an instant. I thought they were gone after that but he later told me the stabbing headaches continue, along with horrible pain in his legs, and ringing in his ears. He told me recently that the symptoms stopped exactly two weeks later but his legs are hurting again.
Child presented with morbilliform rash, upper ? vascular, MMR on 11-12-05.
a very big reaction to second shot; loss of balance; brain not operating correctly, the patient couldn't think straight; had trouble getting up and getting to the bathroom  and back and when the patient laid down, the patient might never get up; really extreme fatigue; headache; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a very big reaction to second shot), BALANCE DISORDER (loss of balance), THINKING ABNORMAL (brain not operating correctly, the patient couldn't think straight), HYPOKINESIA (had trouble getting up and getting to the bathroom  and back and when the patient laid down, the patient might never get up) and FATIGUE (really extreme fatigue) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Overweight and Blood pressure high.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (a very big reaction to second shot), BALANCE DISORDER (loss of balance), THINKING ABNORMAL (brain not operating correctly, the patient couldn't think straight), HYPOKINESIA (had trouble getting up and getting to the bathroom  and back and when the patient laid down, the patient might never get up), FATIGUE (really extreme fatigue), HEADACHE (headache), NAUSEA (nausea) and CHILLS (chills). At the time of the report, VACCINATION COMPLICATION (a very big reaction to second shot), BALANCE DISORDER (loss of balance), THINKING ABNORMAL (brain not operating correctly, the patient couldn't think straight), HYPOKINESIA (had trouble getting up and getting to the bathroom  and back and when the patient laid down, the patient might never get up), FATIGUE (really extreme fatigue), HEADACHE (headache), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.            No Concomitant Medications were provided by the reporter.  No Treatment Information were provided by the reporter.  The patient had all the symptoms to the extreme for about 30 hours.   This case was linked to MOD-2021-374058 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Significant Followup received contains updated reporter's Information, updated patient's demographics and new events are added
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant product use was not provided by the reporter.No treatment information was provided.It was reported that vial was left at room temperature overnight post puncture.This case was linked to MOD-2021-403861 (Patient Link).
Itching all over body, rash on face - took a Benedryl - this started immediately after shot.  About 7 hours later, I was aching all over, had a headache, nausea, and my heart rate was odd.
h/a, nausea, dizzy, malaise, chills which cont 6 days post vax;denies vomiting;denies fever;no rxn to prev two doses 4SEP97 & 6OCT97;
feel crappy; Vaccination site pruritus; Vaccination site swelling; left arm was very sore; low grade fever; Vaccination site pain; anaphylaxis reaction; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (anaphylaxis reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rheumatoid arthritis, Scleritis, Migraine, Headache, Asthma, Diaphragmatic hernia, Antiphospholipid syndrome, Hypertension, ANA, Hashimoto's disease and Anaphylaxis (Anaphylaxis reaction in the past to Levaquin, sulfa, flu shot, latex gloves, pineapple, shrimp, lobster tail, raw tomatoes, most adhesives, and gadolinium contrast dye.). Concurrent medical conditions included Peanut allergy (anaphylaxis reaction - There was twice). Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), DABIGATRAN ETEXILATE MESILATE (PRADAXA), LEFLUNOMIDE, PREDNISONE, MONTELUKAST SODIUM (MONTELUCAST), LEVOTHYROXINE SODIUM (SYNTHROID), SALBUTAMOL SULFATE (VENTORLIN [SALBUTAMOL SULFATE]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), DULOXETINE HYDROCHLORIDE (DULOXETINE [DULOXETINE HYDROCHLORIDE]), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), TOPIRAMATE, LOSARTAN, HYDROCHLOROTHIAZIDE, VITAMIN C [ASCORBIC ACID], CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), DICLOFENAC DIETHYLAMINE (VOLTAREN EMULGEL) and SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for an unknown indication.    On 21-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylaxis reaction) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced FEELING ABNORMAL (feel crappy), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE SWELLING (Vaccination site swelling), MYALGIA (left arm was very sore), PYREXIA (low grade fever) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, ANAPHYLACTIC REACTION (anaphylaxis reaction), FEELING ABNORMAL (feel crappy), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE SWELLING (Vaccination site swelling), MYALGIA (left arm was very sore), PYREXIA (low grade fever) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            Lab data was not provided Treatment product was not provided by the reporter.  Company comment: Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.
3 inch area of erythema, induration and pruritus at site of injection.  Vaccine booster given 32. after initial.
Rash to upper torso and neck, itching from rash and in mouth. Pt received vaccine at 11:55 and started having a reaction by 12:30.
Medical assistant gave menquadfi 1 day early from scheduled dose needed. vaccine OK to give up to 4 days early from 16th birthday but patient was 5 days away from 16th birthday instead. contacted local health department for guidance and they said dose was invalid and needed to be repeated. mom declined need for repeat at this time but will consider in future if needed for college. no symptoms or adverse reactions occured.
Pt Received H1N1 vaccine. While standing at check out counter she passed out, fell forward, struck her face (rt side) and chin on the counter then fell down onto buttocks landing in a sitting position.
The next morning, I noticed swelling and hardening of my lymph nodes in my left armpit. A lot of tenderness. It lasted probably a week. Each day being a little better than the first day.
This spontaneous report as received from a nurse regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 30-JUL-2015, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # L008664, expiration date 03-NOV-2016 and lot # K008409, expiration date 04-MAR-2016 and lot # K018528, expiration date 14-APR-2016. No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Woke the next morning (04/20/21) with severe joint pain and stiffness. Could not negotiate stairs. Hard time walking after sitting. All joints effected: knees, hands, wrists, etc. Although it got a little better, it persisted for months. July 13, 2021 I called gp asking for RA testing. Blood work came back negative for rheumatoid arthritis. Appt with FNP on August 19. He referred to a rheumatologist. Appt with on 10/13/2021. By this time, six months later, the pain and stiffness had almost completely resolved. Diagnosed with vaccine-induced polyarthralgia syndrome. No treatment needed at this time.
Patient 17 years of age was administered a moderna booster shot 0.25 ml (currently not authorized/approve). This error was discovered. Patient did present and adverse affected. Instructed and counsel to monitor for side effects.
pt recvd vax & exp palpitations, tachycardia, anxiety, malaise & a drop in pulse from 130 to 112;
Patient self-reported a fever,  stomach pain, pain between should blade, flu-like symptoms, and pain radiating down the back of his leg.
Menstrual cycle disruptions  - continuing to monitor , reported to doctor in October 2021
Seen 11/12/2016 for complaints of constipation. He was also having some vomiting but was keeping fluids down. Abdomen was distended. He had air/fluid levels on abdominal x-ray. He was sent home with instructions to use glycerin suppositories. He stooled after one suppository was used. The stool passed was bloody/mucousy. He returned for evaluation and was then diagnosed with intussusception. He required surgical correction for this.
Diarrhea; stomach ache, rated pain as 7 out of 10, 10 being the highest; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (stomach ache, rated pain as 7 out of 10, 10 being the highest) and NAUSEA (Nausea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (stomach ache, rated pain as 7 out of 10, 10 being the highest) and NAUSEA (Nausea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at a dose of 1 dosage form. At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (stomach ache, rated pain as 7 out of 10, 10 being the highest) and NAUSEA (Nausea) had resolved.            No concomitant medications were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Significant FU received as "update on outcome ". The symptoms settled in about four days. No issues after that. She said she is fine.
This spontaneous report was received from a registered nurse referring to a 4 month old patient of an unknown gender. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On 15-SEP-2016, the patient was vaccinated with the first dose of ROTATEQ orally (lot # M005732; exact dose and expiry date were not reported). The patient did not experience an adverse effect. No additional doses of ROTATEQ were administered, at the time of the report. Additional information has been requested.
Headache and achy feeling that lasted a couple day. On the second evening I had a 3" band of rash accross my lower rib cage. My ears are still ringing 4 dats later. I have occasion skin pain in a couple areas for no apparent reason (no bruse or redness).
The evening of the vaccination, 03/09/2021,  I started to develop chills, fever, sweats, a metallic taste in my mouth and nausea and that lasted for 24 hours. So I thought I had a nice robust human response.  I tested positive for COVID- 19,  08/22/2021 Via rapid test,  but I already had a fever of 102 fever at that point. My fever went up to 103.8 that evening. And I had fever on and off,  up to 102 for five days. I contacted my provider on the 08/24/2021, he said I  was not high risk so continue to take over-the-counter meds.  I think I have recovered. I have not had a physical. I believe I have recovered .
pt seen for allerg rxn to flu shot;pt reports pruritus & very mild tightening of chest;had flu shot every yr w/o difficulties;localized erythema of face & neck w/hives;BP 110/68, P60 & t99;poss allerg rxn;
Patient returned to pharmacy w/ baseball size red area around injection, warm to touch. We call Dr. He will follow up w/ pat. Told to use ice and take BENADRYL.
in order, Lightheaded Nausea, pain, Swelling, redness, Fever all over. tired. Dehydrated, all within 24 hours. Starting almost within an hour of injection. Primary Care Doctor on vacation so I went to the hospital ER. 2nd Shot not as bad, but did get pain and some swelling. A little bit of redness.
the day Moderna & Flu shot I was very sore tired and feverish.  I had never had a reaction this sever with the 4 prior Moderna Covid 19 Vaccinations.  After this my Left Leg started to go numb also my pinky fingers on both right and left hands. in December 2022 my entire saddle area went numb and my left foot on top of the already numb areas I had. No outcome.  Just come back in 1 year unless symptoms worsted.  No answers.
Swelling within 10 minutes. Face and body. Had to use Benadryl.   Diagnosed with multiple deep vein blood clots  Hemiparesis, apraxia, stroke, prescribed lifelong blood thinners
Local reaction to upper lf deltoid, red, 3 1/2" x 2" induration
Ate an apple at 15:00 on 10/17/00 and felt nauseous. Experienced stomach cramps. On 10/18/00, awakened with a red rash on chest. Nausea resolved but continues with slight rash on chest.
SORE UPPER RT ARM, WARM TO TOUCH, SLIGHTLY SWOLLEN, NO FEVER, NO TYLENOL OR MOTRIN GIVEN BY MOTHER.
Bell's Palsy. Symptoms include right sided facial weakness, eye drooping. Onset was around 12:30 on 1/28. Went to walk in clinic where MD confirmed Bell's Palsy and prescribed Valacyclovir and Prednisone. Started medications around 5pm on 1/28.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly doses of (Oka/Merck) VARIVAX (route, dose and lot # not reported). The temperature excursion for (Oka/Merck) VARIVA was unsupported with in house stability data. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
fever, chills, joint pain, nausea, exhaustion, pain and swelling in arm for two days.  Pain and severe swelling in arm still present on  day 3.