chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Next day post vax, the pt had what appeared to be an allergic reaction. She turned black and blue from the waist down and had a red rash. On one side of her body, the foot and hand swelled up like an elephant. The following day the other side of the body, the foot and hand swelled up like an elephant. It was noted that the pt's eyes were also swollen shut. It was reported that the pt's experiences lasted approximately 4-5 days. The pt's mother did not seek medical attention but did contact the physician who advised her to give her daughter Benadryl.
Arm is itching; made it worse by scratching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm is itching) and SCRATCH (made it worse by scratching) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0020L0A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PRURITUS (Arm is itching) and SCRATCH (made it worse by scratching). At the time of the report, PRURITUS (Arm is itching) and SCRATCH (made it worse by scratching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
p/vax pt exp numbness in mouth & throat;saw MD;dx w/Bells Palsy;
Red rash from head to toe with heat. Recommended to give Benadryl. The rash is still present to date.
On 11/19/12 the patient was vaccinated at approximately 9:40 am & immediately post vaccination the patient stated she felt nauseous; however, the patient had not had anything to eat for breakfast. At approximately 10:20 am, the patient stated she felt dizzy, so out of an abundance of precaution a decision was made to call 911 so that the patient could receive advanced medical care.
Information has been received from a registered nurse concerning a female (age not reported) with pertinent medical history and drug reactions/allergies reported as unspecified who on 28-JAN-2007 was vaccinated with Gardasil (lot# not reported), 0.5 ml IM. Concomitant therapy was unspecified.  On approximately 28-JAN-2007, the patient experienced redness at the injection site with tingling in her arms. The condition progressed to tingling in her fingers with numbness in both arms and fingers. The patient sought medical attention. At time of reporting, the patient had not recovered.  Additional information has been requested.
Severe chills; disoriented; confused; haze over words; couldn't remember what people told him; mental lag; confusion; temperature; This spontaneous case was reported by a patient and describes the occurrence of BODY TEMPERATURE INCREASED (temperature), CHILLS (Severe chills), DISORIENTATION (disoriented), CONFUSIONAL STATE (confused) and SPEECH DISORDER (haze over words) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced BODY TEMPERATURE INCREASED (temperature). On 06-Mar-2021, the patient experienced CHILLS (Severe chills), DISORIENTATION (disoriented), CONFUSIONAL STATE (confused), SPEECH DISORDER (haze over words), MEMORY IMPAIRMENT (couldn't remember what people told him), DISTURBANCE IN ATTENTION (mental lag) and CONFUSIONAL STATE (confusion). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 06-Mar-2021, BODY TEMPERATURE INCREASED (temperature) had resolved. At the time of the report, CHILLS (Severe chills), DISORIENTATION (disoriented), CONFUSIONAL STATE (confused), SPEECH DISORDER (haze over words), MEMORY IMPAIRMENT (couldn't remember what people told him), DISTURBANCE IN ATTENTION (mental lag) and CONFUSIONAL STATE (confusion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Lab data: Temperature 101.6  Concomitant product use was not reported.   Reporter did not allow further contact
No other AE reported; incorrect product storage; This spontaneous report was received from a person of physician's office, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 07-JAN-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0,5 ml, lot # 1602284, expiration date 26-SEP-2021 for prophylaxis (strength, route and frequency were not reported).  The temperature excursion was of 31.2 Centigrade degrees (°C) during 30 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No other adverse events were reported. This is one of several reports received from the same source. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Low-grade fever/chills, headache, fatigue, nausea, neuralgia all over my body (skin hurt and hypersensitive to touch), extreme muscle, joint & bone pain ( focused primarily in knees, hips, shoulders, hands, neck, lower back & tailbone for 2.5 days following my second dose of the Moderna Covid vaccine. Extreme pain was worst the evening / night of 04/06, all day & night on 4/07, and in the morning and afternoon on 04/08. Pain started to resolve in the evening on 04/08.
Full body rash/boils and itching since Monday. He said chicken pox? Fever and body aches.
staff member was asked by writer if she had any anaphylactic reaction to any previous vaccines in the past and she stated NO but was nauseated and felt funky from the flu shot.  covid vaccine given at 1523 and approx. 3 -4 minutes after in the observation area she started stating that she felt numbness in her mouth and felt funky. she also was a little tachy and shaky of her upper extremities.  we followed standard protocol for infusion reaction and gave 1 dose of epinephrine stat and activated emergency response system.  she started to feel better but was nauseous.  EMS arrived and no other doses of epinephrine administered.  EMS transferred to ER.
started to blister; seems that classic shingles attacked; classic shingles skinny eruption; staving pain in her hips; suspected was shingles; This spontaneous case was reported by a consumer and describes the occurrence of LIP PAIN (staving pain in her hips), HERPES ZOSTER (suspected was shingles), BLISTER (started to blister), HERPES ZOSTER (seems that classic shingles attacked) and RASH (classic shingles skinny eruption) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046421A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced LIP PAIN (staving pain in her hips), HERPES ZOSTER (suspected was shingles) and RASH (classic shingles skinny eruption). On 19-Apr-2021, the patient experienced BLISTER (started to blister) and HERPES ZOSTER (seems that classic shingles attacked). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LIP PAIN (staving pain in her hips) and BLISTER (started to blister) outcome was unknown and HERPES ZOSTER (suspected was shingles), HERPES ZOSTER (seems that classic shingles attacked) and RASH (classic shingles skinny eruption) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21-May-2021: event shingles outcome was updated.
Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. There was no medical history or concurrent condition reported. The healthcare worker reported dose of oral, ROTATEQ (lot # K005394, expiry date 23-FEB-2016), which were exposed to temperatures outside of the recommended range, had been administered to unspecified patients on unspecified dates since 15-SEP-2015. No adverse effect has been requested. This is one of several reports received from the same reporter. Addiitonal information has been requested.
This spontaneous case reported by a patient, describes the occurrence of dyspnea (shortness of breath), oral paresthesia (tingling in tongue), pyrexia (fever), chills and extreme fatigue in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. The patient's past medical history included anaphylactic reaction to vaccine. Patient stated she had an anaphylactic shock with another vaccine, not Moderna. On Apr 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient had dyspnea (shortness of breath), oral paresthesia (tingling in tongue), pyrexia (fever), chills, extreme fatigue and myalgia (soreness). At the time of the report, dyspnea (shortness of breath), oral paresthesia (tingling in tongue), pyrexia (fever), chills, extreme fatigue and myalgia  (soreness) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.  No concomitant medications provided. Patient reported she had a "problem with epinephrine." No treatment reported for these events.
Broke out in shingles, same day of 1st dose; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-OCT-2022 Reporter's Comments: This case was received from consumer via  interactive digital media. The patient received 1st shingles dose of Shingrix and broke out in shingles the same day. The patient wanted to know should he/she get the 2nd dose. The follow-up could not be possible as no contact details were available.
Very hard lump at injection site about 4" in diameter for 2 days. Redness at injection site for 2 days. Swelling at injection site for 2 days.  Soreness at injection site for 5 days. Tiredness, muscle aches, headache, shivering, fever, nausea for 2 days.
No adverse effects; needle bent; child received a partial dose of PROQUAD; This spontaneous report was received from a registered nurse and refers to a 4-year-old female patient. The patient's pertinent medical history, concomitant therapies, drug reactions and allergies were not reported.  On 23-AUG-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection in the right thigh (lot # S002497 and expiry date 23-JUL-2020; exact dose was not provided) which was reconstituted with sterile diluent (lot # S000978 and expiry date 22-JUL-2021) for prophylaxis. There was administered a partial dose, because the child was moving so much during the vaccination, that the needle bent and the syringe had to be removed from the thigh. The needle disengaged from the syringe and the remainder of the product was lost on the table. No adverse effects were reported. The outcome of the event was unknown.  The causality assessment was not provided.
This patient had redness (onset at 2:40) at the site of Prevnar injection, resolving spontaneously during 48 hours after vaccinations.
This spontaneous report as received from a 58 years old pharmacist refers to herself with drug reactions/allergies to sulfa and sulfamethoxazole, MICROBID and no pertinent. The patient was vaccinated with a dose of ZOSTAVAX (Lot# not reported) SQ on 29-MAR-2012. No other co-suspects were reported. Concomitant medications included ALTACE, NEXIUM, SYNTHROID and LAMICTAL. The pharmacist was reporting that she was diagnosed with "Henoch Schonlein Purpura" after receiving ZOSTAVAX. She developed "dots" on skins and joint pain on her ankles, feet, hands, and wrists. She was first treated with doxycycline thinking that it might be lyme disease but the blood test was negative. A biopsy was done and it was confirmed that it was Henoch Schonlein Purpura. The patient sought medical attention. Prednisone and cortisone injection were given for treatment. The AE onset date was in April 2012, "within 3 weeks of vaccination". At the time of reporting, the patient was not recovered. This is one of several reports received from the same source. Additional information has been requested.
Headache, fever, muscle aches, weakness. Tylenol, which didn't help much. Lasted 2 1/2 days and then symptoms resolved. Also red, hot, swollen, sore knot the size of a baseball on my arm where vaccine was injected.
Pt was given zoster vaccine 7/20/12. Pt had vaccine 10/15/10.
pt cried p/shots; heart rate inc & resp became shallow; pale in color; never lost consciousness or arrested;
On first day child react w/ vaccine left deltoid. SQ, swollen, given Benadryl and apply ice.
Received shingles vaccine, had a red rash about 3 inches long for a couple of weeks. Now my right shoulder and muscle on my upper right arm is sore from it. It is tender to the touch. Can't use my arm in the backward motion. X-ray later but couldn't find any thing so I think it just settled in my muscles.
Presented with red, warm area measuring 50mm x 30mm at injection site. Pt denies discomfort. Pt informed RN on 8/24/06 that she had a light case of measles in childhood, but decided to get MMR vaccine during state outbreak. MMR #1 given 5/30/06, MMR #2 given 8/22/06.
Fist even was a mild reaction of soreness at sight, odd metallic taste for about a week. Second dose I began with with pain and swelling in my lymph glands under the arm where injection was given. I went to the clinic after several days of this worsening. Instructions per dr were to let it ride for another couple of days so my natural immunity could do it's job. But, if worsened to return. They called with follow-up. Swelling had subsided, and pain lessened. But, it spread to other lymph on the left side. Additionally, I had an odd taste again. The immune system was working but pain only lessened about early June. On June 16, 2021, I awoke with a pain in my center chest, like a pulled muscle. It has since spread across my diaphragm area under the breasts. This may or may not be related. It is still uncomfortable but not as severe today, at 2 weeks+. I had my least clear mammogram on March 4,2021 (3D) prior to March 9, 2021 first COVID19 injection.
All of her body aches; Chills; This is a spontaneous report from a contactable consumer (patient's husband) reported for his wife.    A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included heart murmur, asthma. Concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation without adverse event. On an unspecified date, the patient experienced all of her body aches, chills. Therapeutic measures were taken as a result of the events included Tylenol. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's; This spontaneous safety report, with reference number 02299086 (Interaction # 02299043) was received by the partner on 19-DEC-2022 and forwarded on 21-DEC-2022, from a health professional.   Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis was not applicable.   Further information is expected.  For reference purposes, this case is linked to MCM-004406, MCM-004408, MCM-004409 and MCM-004407 (same reporter).  SIGNIFICANT FOLLOW UP INFORMATION was received on 03-JAN-2023 from the health care professional.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis remains not applicable.  No further information is expected.
24 hours after vaccine: chills, headache, muscle aches, fatigue, symptoms resolved within 8hrs of onset.  48 hours after vaccine localized swelling at injection site continuing for 3+ days
As soon as vaccine was administered client stated she felt faint. PHN immediately instructed client to put head down between her knees as she was sitting down. Client then had seizure episode. Seizure lasted for approx 5-10 seconds and client recovered. After resting for a few minutes, client stated she felt fine to walk and left with her mother. Mother stated she will let clients doctor know.
Received first dose of vaccine on 12/29/20.  Had no reactions and checked in through Vsafe system.  On 12/31/20, I lost control of my bladder at work.  I did not have the urgency to go, and when I started walking, my bladder emptied.  I reported this symptom through Vsafe on that day.  This symptom did not happen again.  On 1/10/21, I was changing my clothes and my left arm felt itchy.  When I itched my arm, I felt little, raised welts.  I looked at my arm, and a significant red, irregular shaped spot was on my arm.  I could not report this to Vsafe as my check ins had stopped as of 1/6/21.  I called my PCP, who directed me to this site to report it.
Extreme overall body aches (mainly muscles) began about 8 hours after injection followed by intense chills at 9 hours post injection. Low grade fever 99-100F from approx. 9 hours post injection to 18 hours post injection. Pain in right arm (couldn't raise arm beyond 90 degrees to floor) began with intensity about 8 hours post injection. Headache started about 18 hours post injection.  Slight nausea (dry heaves once) around 20 hours post injection.  I took 3  regular strength (325 mg) Tylenol pills over the course of 16 ours and drank 8 oz. of green tea about  24 hours post injection.  Symptoms had largely cleared up by 30 hours post injection.
pt recvd vax & devel a react dx as cellulitis; pt treated w/Duricef;
tested positive for COVID and her doctor prescribed PAXLOVID; tested positive for COVID and her doctor prescribed PAXLOVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu (had all the flu shots.), for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID and her doctor prescribed PAXLOVID". The events "tested positive for covid and her doctor prescribed paxlovid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: Patient had received all the Pfizer 1st, 2nd shot and 2 booster doses of COVID. She received last dose of vaccine in 2022. She was tested positive for COVID and her doctor prescribed PAXLOVID it because of her result. Patient received every shot and never been sick. She wears a mask and live alone. She went to the office, and she saw someone closing the door. It was a small room. She thought she must have gotten COVID from her. That was Friday (unknown date), patient had fever, she didn't have a lot of loss of appetite or headache. Patient felt like she had a strep throat and she waited to see her doctor until the next morning. They told patient if she had a sore throat, she could test positive for COVID. The doctor didn't even send a throat culture. Patient was not sure if she had strep or not. Her doctor prescribed the medication PAXLOVID without ruling her strep throat. The patient thought they should send the strep throat culture before giving her the medication. Patient was dripping wet this morning (14Aug2023). She had hoarseness in her throat. Most symptoms are over. Her fever is going down. Her son who had COVID had to go to the hospital. But her COVID was not that bad that's because she had the shots. It did not affect her breathing. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. Patient asked should she take Paxlovid prescribed by her doctor even after her symptoms have subsided. She did not want to take it because she might experience the side effects associated with it. The reporter considered event as non-serious.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300276322 same reporter/patient/product, different event.;
Arm pain at site,  Tenderness, Headache, Fever over 101.8, Muscle pain, Joint pain, Nausea
Information has been received from a health professional concerning a 47 month old male who on 5/24/01 was vaccinated with a dose of varicella virus vaccine live. On 2/17/04, the patient experienced a rash for 5 days. It was reported that he had just visited cousins who had chicken pox. There were approximately 50 spots, scattered and scabbed. Symptomatic treatment was given and the patient subsequently recovered from the rash. Additional information is not expected.
A pt who received a dose of Flu-Sheild on 12/20/2000 subsequently experienced pain in all her joints. She was seen by a physician and prescribed oral Prednisone. She indicated that she was allegedly dx with post traumatic arthritis 8 days post vaccination. As of 06/26/2001, she stated that pain persists her right ankle only. Follow-up received from the pt on 9/11/02, stated that a lymph node biopsy will be performed mid-September 2002, for possible sarcoidosis.