chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle ache; fatigue; Elevated HS-CRP; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included heart disorder.   In March 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced muscle pain, fatigue and high-sensitivity c-reactive protein increased. On an unknown date, the outcome of the muscle pain, fatigue and high-sensitivity c-reactive protein increased were unknown.   It was unknown if the reporter considered the muscle pain, fatigue and high-sensitivity c-reactive protein increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comment: The member of public reported that, she had received Shingrix and her blood was drawn 40 hrs later, the results of the blood work came as elevated HS-CRP (High-sensitivity C-reactive protein) and would like to know if Shignrix could cause it.  The patient also experienced muscle ache and fatigue after the shingrix shot. The reporter consented to follow up.
Moderna COVID-19 Vaccine EUA: Patient woke up at 2:30 AM after having vaccine the previous morning.  She stated she felt thick headed and could not see. Patient stated she fell twice and presented to pharmacy 11/5/21 with bruising on face.
This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (heartburn), ILLNESS (in bed sick), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), FATIGUE (fatigue) and CHILLS (chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 044A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Hypothyroidism, Hypertension and Triglycerides. Concomitant products included CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE (CHONDROITIN GLUCOSAMIN) for Arthritis, ALLOPURINOL, BIOTIN, CALCIUM CITRATE, CELECOXIB, CLONAZEPAM, COLLAGEN, DILTIAZEM, CONJUGATED LINOLEIC ACID, LINUM USITATISSIMUM SEED OIL, UBIDECARENONE (COQ10 [CONJUGATED LINOLEIC ACID;LINUM USITATISSIMUM SEED OIL;UBIDECARENONE]), ESOMEPRAZOLE, GABAPENTIN, BISACODYL (LAXATIVE [BISACODYL]), GLIPIZIDE, HYDROCHLOROTHIAZIDE, LORATADINE, LOSARTAN, IRON, PAROXETINE, DOCUSATE SODIUM (STOOL SOFTENER), DENOSUMAB (PROLIA), RISPERIDONE, ROSUVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID), HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ), CURCUMA LONGA ROOT, PIPER NIGRUM FRUIT (TURMERIC CURCUMIN [CURCUMA LONGA ROOT;PIPER NIGRUM FRUIT]) and COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, the patient experienced DYSPEPSIA (heartburn), ILLNESS (in bed sick), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), FATIGUE (fatigue), CHILLS (chills), NAUSEA (nausea), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and VACCINATION SITE PAIN (arm little sore). The patient was treated with CALCIUM CARBONATE, MAGNESIUM CARBONATE (TUMS [CALCIUM CARBONATE;MAGNESIUM CARBONATE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPEPSIA (heartburn) and VACCINATION SITE PAIN (arm little sore) had not resolved and ILLNESS (in bed sick), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), FATIGUE (fatigue), CHILLS (chills), NAUSEA (nausea), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
This case was reported by a pharmacist (mother of the subject) and described the occurrence of swelling injection site in a male subject aged between 0 and 9 years old who was vaccinated with DTaP vaccine (manufacturer unspecified). Concurrent medical conditions included reactive airway disease. Concurrent medications included SINGULAIR, NASONEX and ZYRTEC. On an unspecified date the subject received unspecified dose of DTaP vaccine (unknown route, unknown leg). At an unknown time after vaccination with DTaP vaccine, the subject experienced swelling injection site. The reporter stated that "the last dose of DTaP: swelling of leg where vaccine was given." The pharmacist also reported adverse experiences to another vaccine. See case A0998237A for details.
1st shot of Moderna was on September 10, 2021 and resulted in a low grade fever of 99.2, pain at the injection site plus a large swollen knot under the skin. I had leg muscle aches and flushing of the face and body.  2nd shot of Moderna was October 22,  2021 and resulted in dizziness, lightheaded, nauseous for 1.5 hours lying on the bathroom floor and a fever of 100.2 plus body aches and flushing . It wasn't until a month later that I noticed being itchy all over after eating foods either on my Allergy list and those NOT on the list. Since December, things have gotten much worse where I itch severely every day from head to toe and forced me to eliminate those foods that triggered itching, corn, wheat and potato. After nearly 3 weeks, I was still itching and after eating foods I knew I never itched from before. Upon looking up data on the Internet, I discovered that other people were experiencing similar issues with itching, hives and rashes weeks to months after the Moderna 2nd vaccine. Today, 2/16/22, I still itch from head to toe whenever I eat what I think are safe foods to eat prompting to think that the itching is NOT being triggered by the safe foods but by something else....the 2nd vaccine since I had an adverse reaction after the 2nd shot in October.
Patient reported excessive sweating, mild confusion, dizziness. Advised to self monitor and seek medical attention if worsening, may treat with APAP, fluids, rest, and diphenhydramine.
Started to get chills - 3 pm. Rash and went unconscious - 8 pm. Fully recovered by next day (10/29/16). Slight cold still. No treatment received.
8-12 hours after shot: Extreme chills with uncontrollable shaking, skin paleness, chest tightness, 12-28 hours hours after shot: Severe headache 30-38 hour after shot: extreme sweating, without apparent fever or feeling hot  COVID Vaccine COMIRNATY 2023-24(12Y UP) SYRG
Information has been received from a nurse concerning unspecified patients of unknown age and gender. On unspecified dates, the patients were administered with GARDASIL 9 (dose and route not provided, lot# L023230 with expire date of 28-JUL-2017), which was exposed to temperatures outside of the recommended range (Incorrect product storage). The conditions storage was 11 Celsius degree for 1333 hours, 41 minutes. There was no previous temperature excursions. No adverse effects have been reported. Additional information has been requested.
Had shingles shots, got a mild case of shingles/Suspected vaccination failure; Mild case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 02-MAR-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had shingles shots but still had a mild case of shingles.  The patient was glad sure that had the shots. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Began to have edema around my ankles, feet and lower leg. Contacted my primary Doctor and he never heard of fluid retention as a side affect of the shot and prescribed furosemide. I continue to have fluid retention today, 2 months after first shot. My spouse- received shots on same day and also retained fluid in same areas. However, her skin broke open and drained fluid for 2 days. Her swelling has reduced now. She has had previous heart attack and I have renal failure.
This spontaneous report concerning a male patient of unknown age, was received from the patient's wife. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, frequency, route of administration, lot number and expiration date were not reported). On an unknown date, the patient got shingles, went right the doctor and got his medicine. It was reported that he was out of comission for about a week. The outcome of herpes zoster was reported as recovering (also reported as unknown) as the patient felt better after taking his medicine. The causality assessment between the event and the suspect product was not reported. This is one of several reports received from the same reporter. Additional information is not expected as there is not consent to follow-up. Sender's Comments: US-009507513-1611USA012814.
Tested Positive after the 1st dose; This is a spontaneous report from a Pfizer-sponsored program Pfizer. A contactable female consumer (patient) reported that female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Tested Positive after the 1st dose. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
HAVE NOT GET PERIOD CYCLE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced have not get period cycle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of have not get period cycle was not reported. This report was non-serious.
Diagnosed with shingles less than 2 weeks after receiving second vaccine; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0151, Expiration date: not reported), via an unspecified route of administration in arm right on 15Apr2021 at 10:45 AM (at the age of 41-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included known allergy to penicillin. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER0727, Expiration date: not reported), via an unspecified route of administration on 25Mar2021 at 10:15 AM (at the age of 41-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as no. No Covid prior vaccination and no Covid tested post vaccination. The patient received other vaccine same date vaccine date was on 15Apr2021. On 20Apr2021, the patient was diagnosed with shingles less than 2 weeks after receiving second vaccine. This resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for the event and treatment medications included anti-viral medication and cortisone cream. The outcome of the event was not recovered. No follow up attempts are possible. No further information is expected.
Previously G1P1, delivered normal healthy baby July 20, 2020. Second pregnancy conception 12/15/2020. First vaccine dose 12/22/2020. Vaginal bleeding started 1/2/2021 and tapered down 1/4/2021. Light bleeding continued 1/4/2021 - 1/18/2021. Second vaccine dose administered 1/12/2021. Bleeding increased from light/none to medium flow on 1/19/2021 - 1/22/2021. Home urine pregnancy tests positive x 2 on 1/22/2021. HCG 56 mIU/mL and progesterone 0.5 ng/mL on 1/22/2021. HCG 17 mIU/mL and progesterone <0.5 ng/mL on 1/25/2021. Bleeding decreased to light flow 1/22-1/25 and gone 1/26/2021. Dr. diagnosed as early pregnancy loss/miscarriage.
Patient stopped by pharmacy 2 days after receiving shot with a red raised rash around the injection site. Rash does not itch, but patient stated it burned and referred the patient to see her PCP.
Area of muscle around his neck where he had the surgery was bothering him; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Area of muscle around his neck where he had the surgery was bothering him) and HEADACHE (Mild headache) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Stent placement (stent placed in his right carotid).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Area of muscle around his neck where he had the surgery was bothering him) and HEADACHE (Mild headache). On 26-Jan-2021, MUSCULOSKELETAL DISCOMFORT (Area of muscle around his neck where he had the surgery was bothering him) and HEADACHE (Mild headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-023672 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: The patient informed that he was doing fine and declined further follow up.
Information has been received from a physician concerning a female with a history of hives from penicillin who on an unspecified date was vaccinated with the first dose of GARDASIL vaccine. Later in that day the patient developed a rash, slightly raised if scratched, pruritic, over her trunk and arms. Subsequently, the patient recovered from rash which lasted for 5 to 7 days. Additional information has been requested.
Vaccine given on 9-16-09 @ 245/PM.  Pt. developed "severe headache & vomiting overnight" (per mother)
Redness,  Hardness, Swallowed, a little warmer around the area of the injection appeared 10 days  after my first dose. Day one: when reaction appeared was some redness. Day two: the redness extended and my arm swallowed and also the harness of my muscle. Day three: still some redness , warm but the swalloded part decreased a little.
Pt spiked temp of 102 r despite APAP; Fussy following vax; Not seen in ER or by MD;
Nausea, diarrhea, chills, body aches, shortness of breath, fatigue, muscle aches, headache, sore throat
severe swelling, redness of inj site;fever 103-104 for 1 days;cellulitis of inj site;
Information has been received from a physician concerning a 16 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL.  After receiving GARDASIL the patient passed out, her lips went blue and she was very pale.  The physician reported that the patient had passed out for about two to three minutes and then she was fine and left the office.  The physician was unsure if the patient was going to receive any additional doses of GARDASIL because of the fainting.  The patient sought physician's medical attention.  Additional information has been requested.  This is in follow-up to report(s) previously submitted on 8/14/2008. Follow-up information was received on 26-AUG-2008 from the physician concerning a 16 year old female student who at 3:00 p.m. of 26-JUN-2008 was vaccinated in the left arm with a first dose of GARDASIL (Lot #656050/0245U). There was no illness at time of vaccination. The patient was at the office for a well-visit. Concomitant therapy included TUBERSOL (Lot #C2908AA), HAVRIX (Lot #AHAVB234BA) and MENACTRA (Lot #U2621AA). At 4:00 p.m. of 26-JUN-2008 the patient fainted. Her lips turned blue and she was very pale. On 27-JUN-2008 the patient recovered from the events. Additional information is not expected.
CP (about 1 month prior to ED visit), SOB, nausea, sweating
Strong stomach pain for several days, lingering stomach pain 1 week after vaccination. The pain was bad enough to require bed rest for one full day, and lasted about 4 days at that level of pain. There was a corresponding reduction in appetite, although eating did not seem to worsen stomach pain. No nausea. One week later and I still have some stomach pain. What is unusual is a rash inside the left arm running in a line from wrist to shoulder, which remains as of this writing one week after vaccination. No sensation regarding the rash: no pain, itch, or other sensation. My GP said it looked like shingles without blisters. I also reported the symptom to the pharmacy where vaccination took place. No explanation for the "rash", which I have never experienced before. Several years ago I received the previous version of the Zoster vaccination and had no side effects of any kind.
I had chills, bone chilling chill, then I had a fever 102. Then I started getting body aches and sore throat. About day 6 I started having difficulty getting up steps and tested for COVID-19. I had extreme fatigue. On day 8 I went got the monoclonal antibodies about the time I started having breathing treatments. I got blisters on my tongue. I still have brain fog.
Moderna vaccine was administered 2/18/2021 lot # 031M20A. Client dx with covid on 2/21/2021 and given monoclonal antibodies on 3/2/2021
hearing loss; postherpetic neuralgia; multiple outbreaks of herpes zoster; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot number and expiry date were not provided), for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date after receiving the zoster vaccine live (ZOSTAVAX), the patient suffered multiple outbreaks of herpes zoster, postherpetic neuralgia and hearing loss. As a result of these symptoms, she was seen and treated by medical providers and was still under their care. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), her symptoms resulted in physical limitations not present prior to using it. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of hearing loss was determined to be medically significant. The events of multiple outbreaks of herpes zoster, postherpetic neuralgia and hearing loss were considered to be disabling.
6/16/04 Began bruising. 6/21/04 Bruising all over body; some with lumps, petechia noted. Appointment with physician. 6/22 Blood draws; appointment made for treatment at hospital. 6/30/04 Injection of WinRho at outpatient. This is about 3 yr old female whose history dates back about a week or so when they first noted that she was starting to have some excess bruising. They saw their family doctor and the lab there showed that the child had some degree of thrombocytopenia. Repeat clinic visit was done and there family physician spoke with hematologist. Repeat labs showed that the platelets had dropped down to 17,000. It was felt that this was ITP and may be due to the fact that the child had just recently received MMR and Varicella vaccines as well as contact with hand foot and mouth virus in a brother. The child was at the hematology clinic where she received an injection of WinRHO for treatment of her low platelets. They waited an hour to make sure there was not an immediate allergic reaction and were discharged from the clinic. The child did not appear to have any problems and in fact did eat a cheese sandwich during the period of observation. The parents were driving home and the child began having some vomiting and seemed to be in distress, so they pulled off here and stopped at the ER for further evaluation. She was noted to have a fever at triage but until that time, the pt were unaware that the child was having any problems with fever. The symptoms of vomiting again just started in the 30 minutes prior to them making it here to the hospital where she had several bouts of retching and vomiting. There was no diarrhea. She did not have any change in her level of mental status.  Nurse follow up on 10/06/04 states: "ITP, fever, vomiting."
Blood noted in urine, flank and urethral pain similar to previous experience with kidney stones in the past (over 15 years prior), no visual stone observed.  Fever=101.5, chilling on 1/28/21.  2nd dose of Moderna received 1/26/21.  Typical local reaction of redness, swelling, pain at injection site.  HA, fatigue, body aches.
4 mo old M 5 days after vaccines below dev. emesis 10-15 times, followed by dark stool; following pasty, red streak stool UGI -> NL; u/s -> intussusception; air contrast - reduced; stool guaiac (+); Rota (-).
Left arm swollen, red and warm. Advised to apply warm moist heat, massage, Benadryl and Motrin. Call if worsens.
Client started with diarrhea 2-3 loose stools/day.  4/2/12 during the evening she started with a rash on her Left arm. She was still having diarrhea.  Rash spread to face, chin, neck, both arms, wrist, hands and ears.  Describes rash as very itchy.  Areas looked like blisters and some were fluid filled.  They were different sizes. Areas eventually crust over like "an old mosquito bite without the swelling".  Also complained of extreme achiness and swelling of hands arms feet and neck.  Client's blood pressure has increased and is now on blood pressure medication. Still had rash at time of phone call 4/7/14.
7 by 2 cm area of erythema/swelling (L) biceps, 2 by 2 cm area of erythema/swelling (R) bicep low grade fever x 24 hours.