chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1 of 4 pts vaxed w/in a 2 wk period from the same lot who exp an inject site react the size of a silver dollar; react consisted of erythema, swelling, & hot to touch; treated w/APAP; pt recovered;
As per patient, smallpox vaccination site had healed ok. On 2/28/04 she noticed small vesicles on vaccination site. Other symptoms that day and the day after included fever, body aches, and night sweats. Patient saw her physician who stated to her that symptoms were not related to vaccine but to bronchitis which she has had for the last three weeks. Patient is taking treatment.
On 05/17/2022, I had aches and joint pains. I woke up and took 2 at-home antigen COVID-19 tests, and they came back positive So I got up and went to the pharmacy to take a PCR test to confirm it; two days later, I got a text confirming I had COVID-19. I contacted my physician's office and informed them. My doctor prescribed methylprednisolone 4mg and azithromycin 250mg. My congestion is practically gone, but I still sometimes wake up with headaches.
SHARP PAIN FOR HALF SECOND IN VEINS ON WRIST, LEG; HEADACHE FOR 2 HOURS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sharp pain for half second in veins on wrist, leg, and headache for 2 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sharp pain for half second in veins on wrist, leg, and headache for 2 hours. This report was non-serious.
The patient appears to have developed acute myopericarditis within 3 days of receiving the vaccine.; This is a spontaneous report from a contactable physician. A 22-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number and expiry date were not provided), via an unspecified route of administration on 31Mar2021 (at the age of 22-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food or other products. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive any other medications within 2 weeks of vaccination. Patient has not COVID, prior vaccination. On 03Apr2021, the patient appears to have developed acute myopericarditis within 3 days of receiving the vaccine (adverse event result in Emergency room/department or urgent care). Patient received treatment with acetylsalicylic acid (ASPIRIN) and colchicine. Patient has been tested for COVID in 2021, post vaccination, Test type: Nasal Swab and result was negative. The outcome of the event was recovering.  Additional information on lot/batch number has been requested.; Sender's Comments: Based on the known vaccine safety profile the causal association between the reported event patient appears to have developed acute myopericarditis within 3 days of receiving the vaccine and the usage of the vaccine BNT162B2 is unlikely but cannot be completely excluded because of strong temporal association between the event and the suspected vaccine. The case will be assessed once the new information is available. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Dehydrated; Dizziness; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (Dehydrated), DIZZINESS (Dizziness), PYREXIA (Fever) and CHILLS (Chills) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEHYDRATION (Dehydrated), DIZZINESS (Dizziness), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DEHYDRATION (Dehydrated), DIZZINESS (Dizziness), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Concomitant medications were unknown.     This case was linked to MOD-2021-030237 (Patient Link).   Reporter did not allow further contact
Information has been received from a certified medical assistant concerning a 72 year old female with hypertension, high blood lipids, depression, gastrooesophageal reflux disease, a penicillin allergy, an allergy to streptomycin, and a hypersensitivity to Sprite, who on 19-JUN-2007 was vaccinated intramuscularly in the right arm with a dose of Zostavax (Oka/Merck).  Concomitant therapy included ezetimibe (MSD), ZESTRIL, hydrochlorothiazide (manufacturer unknown), LIPITOR, ZOLOFT, PROTONIX and ATIVAN.  On 04-JUL-2007 the patient developed a rash and itch at the axillary area of her right arm which spread to her trunk and face.  On 10-JUL-2007 the patient was diagnosed with chicken pox.  Unspecified medical attention was sought.  At the time of this report the patient was recovering.  No other information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Pt admitted  04/27/2021 for AMS and HTN with elevated creatinine.  Pt returned to NH on 05/05/2021
Pt sent to hospital by PCP after falling off exam table post vaccine administration. Patient fell & hit head, no loss of consciousness. Pt lethargic, dizzy, nauseous. Some vomiting. Pt received HPV, MCV4 & Tdap.
Several hours after shot extreme body/joint aches and headache. Took ibuprofen symptoms waned. Later in evening some chills and sweat. Went to bed. at an unknown time I experienced total incapacitation, and what I would describe as an ACID trip. Bright yellow colors followed by shivering and convulsions. Turning to the colors of a electric stove burner getting redder and redder and sweating. Severe vaccine site pain upon every movement whether moving arm or not. If I had been able I probably would have called 911. (I live alone) Around 3:30 am I began to "wake" up and become coherent symptoms gone by 4:30 am unable to sleep, unable to get out of bed. unable to walk/stand. Finally fell into fitful sleep at about 6:30 AM got up at around 12:30 PM severe abdominal muscle pain from convulsions. Took Ibuprofen.  rested on couch all day. Ate very little as unable to fend for myself.  Went to bed. Still very weak the next morning (Thursday). Felt better as the day went on and back to normal on Friday.
I had a little soreness at the injection site for about a day. I noticed after eating certain things that I became blotted, diarrhea and just felt miserable. I was referred to a gastroenterologist and I had an endoscopy and they found that I had Celiac disease.  I am on a restricted diet for the rest of my life.
104+ fever spikes; his head hurt so bad that he thought it was going to explode / felt like a ton of bricks hitting his head; head hurt / slightest/ ounce of light made 10 times worse; head hurt / slightest sound / made 10 times worse; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient exposed to Men B NVS (Meningococcal B vaccine) in utero. The parent received the product for prophylaxis.   On an unknown date, the mother received the 1st dose of Meningococcal B vaccine. The mother's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient was exposed to  at an unknown time during the pregnancy. The patient was diagnosed with fever, headache, photophobia and sound sensitivity increased. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, headache, photophobia and sound sensitivity increased were unknown.   It was unknown if the reporter considered the fever, headache, photophobia and sound sensitivity increased to be related to Meningococcal B vaccine.  Additional details were received as follows: The age at vaccination was not reported.  The patient had very bad reaction, fever with 104 degree F spiked that Tylenol did very little for. He said his head hurt so bad that he thought it was going to explode. The slightest sound or ounce of light made 10 times worse even though he didn't think it could get worse. Me touching his head to place a tempered cloth felt like a ton of bricks hitting his head. I seriously thought we were going to be heading to the ER. I didn't sleep a wink that night as I was so afraid that he was going to die in his sleep. Needless to say he did not get the 2nd dose even though the pediatrician office keep trying to get use to schedule the second dose. My daughter refused after witness the side affects her brother
A nurse reported that a male received Tetanus Toxoid years ago and had a reaction that he almost died.  He recovered.  No further information was available at the date of this report.
On 7/27/23, during immunization reconciliation, the counts for specific lots of Pediatric MMR vaccine and Pediatric MMRV vaccine in system were noted to be discrepant from the physical Count of inventory in the clinic. MMRV (Lot: X007087 Exp: 9/4/24) was showing in system as having 10 doses in inventory with no doses having been administered, however, the physical count revealed only 9 doses in clinic. MMR (Lot: W007041 Exp: 02/29/2024) was showing in system as having 6 doses remaining, however, physical count of the vaccine in the unit was 7 doses. All other inventory counts were correct. 4 patients had documentation in system showing vaccination with this lot of MMR, since last reconciliation. All 4 patients were also vaccinated with Varicella vaccine during each of their visits. Documentation for each of the 4 patients also noted the MMR (and Varicella) vaccinations. Due to the discrepancies in count, however, it can be presumed that one of these children (although we cannot determine which child) were vaccinated with MMRV in the place of MMR and therefore received MMRV and Varicella on the same day inadvertently. RN reported findings to supervisor. Immunization Program Nurse and Regional Director were notified by RN. Dr. was also noted of above information. PHN contacted parents of all 4 minor patients and notified them of the possibility of vaccination error. Mom denies any reaction of any kind after receiving vaccines. Child is currently doing fine.
Brain fog, and an episode of chest pain lasting 5-10 minutes on the day of the injection. Following days had short bursts of chest pain in left chest/breast area in a very pinpoint area. Mild cramping since shot. Headaches.
12/24 headache, low grade  fever, chills  took advil. 12/29 2:30am severe reaction of itching aggressively from scalp to toes, broke out in red hives, tachycardic Itchy throat,  swollen, ears and  lips.
Tingiling in the left hand middle finger 20 minutes after the injection. Resolved in 10 munutes to a slight numbness.
Body aches, temperature of 102.5 F. Pt took Ibuprofen, temperature decreased, and pt felt better in 5 hours.
I gave a 13 year old a booster of Pfizer.  His parents gave consent and I gave vaccine then immediately remembered that a booster cannot be given to patients under the age of 16. I informed parents.
Noted blisters to injection insertion site and around site, ARNP seen today discussed using calamine lotion to site and to report any additional side effects.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 17th July 2018, the patient received the 1st dose of SHINGRIX. On 17th July 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain and feeling of warmth. On an unknown date, the outcome of the influenza-like symptoms, general body pain and feeling of warmth were unknown. The reporter considered the influenza-like symptoms, general body pain and feeling of warmth to be probably related to SHINGRIX. Additional details were reported as follows: The reporter was sister of the patient who provided this information. The patient experienced flu like symptoms, body aches and warm all over. The health care professional did not consider the events to be life threatening. The patient was not admitted to the hospital overnight or prolong an existing hospitalization. Health care professional did not consider the event(s) to result in persistent or significant disability/incapacity. The patient did not experience fatal adverse event and the patient had no congenital anomaly or birth defect. The patient did not require surgical or medical intervention to prevent one of the outcomes described in preceding questions. She was willing to take a call to follow-up on the resolution or any other details needed. Her cell phone was included.
Ringing in left ear beginning 3 weeks after first dose. Did not get worse following second does. Faint ringing still persists 2+ weeks after second dose.
p/vax pt devel inj site rxn @ site;rxn was described as cellulitis affecting the entire arm;
Racing heart; elevated blood pressure; tingling in arm, neck and face; Light headed; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot Number: FC3184), via an unspecified route of administration, administered in Arm Left on 11Sep2021 (at the age of 61-year-old) as dose 1, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); thyroid (ARMOUR THYROID); hydrochlorothiazide, lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA); multivitamin, all taken for an unspecified indication, start and stop date were not reported. The patient previously took (ceftriaxone) CEFTIN, (pseudoephedrine hydrochloride) SUDAFED and experienced allergy. 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 11Sep2021, day of shot, the patient started experiencing racing heart, elevated blood pressure, tingling in arm, neck and face and light headed and it got progressively worse. Events resulted in doctor or other healthcare professional office/clinic visit. Treatment included additional medications to lower bp and pulse. Reporter assessed the events as non-serious. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Repeated shingles outbreaks. Have had shingles a total of  three times since being vaccinated. I have been prescribed valacyclovir to get over it but  it's getting more difficult to get over and now I'm going to have to take a preventative dose.
Five days 18 hours after receiving the Janssen vaccine shot, I awoke with an unusual and very painful headache. Having only been asleep for about two hours, I didn't want to get up and tried to rearrange myself for relief. Getting slight relief, I did fall asleep again after moving around and drinking water over about an hour. I awoke two hours later (about 10:00 AM) with almost unbearable head pain throughout my head, not localized to one area. I drove to fast food restaurant, having a difficult time driving due to pain, and got a half-sweet tea. Tea, having caffeine and some sugar, can often relieve a headache. It didn't offer the relief I expected and about 30 minutes later, I vomited up the tea. I was at that same time ordering a sandwich and detox smoothie, thinking the detox smoothie may help. It seemed to after a couple more hours, but I continued to feel like the headache was still barely there and waiting to return. I ate very well and clean all day, but even late in the evening, I cod feel remnants of a headache. The next morning, 4/12, I awoke again with that same horrible headache, but maybe just slightly less excruciating than the day before. I did not vomit. After a few hours of eating, drinking water, and taking aspirin with Tylenol, the headache subsided.
Local reaction of redness, swelling, and warm to touch about 1/2 baseball size lump. It is itchy. No drainage or fevers. Recommended Ice and BENADRYL cream to site. Continue to monitor.
This spontaneous report was received from a vaccine coordinator (non-health care professional) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates in 2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L038917, expiration date 20-FEB-2018 and lot # M009378 expiration date 23-APR-2018 (dose, route of administration and anatomical location were not provided). The vaccines were refrigerated and exposed to the following temperatures and time frames out of range: 1 Celsius degree for 165 hours between 01-JUL-2016 and 07-JUL-2016, 1 Celsius degree for 126.75 hours between 14-JUL-2016 and 19-JUL-2016, -2 Celsius degrees for 70.5 hours between 22-JUL-2016 and 25-JUL-2016, 1 Celsius degree for 191.5 hours between 28-JUL-2016 and 05-AUG-2016, 1 Celsius degree for 77 hours between 06-AUG-2016 and 09-AUG-2016, 1 Celsius degree for 166 hours between 12-AUG-2016 and 18-AUG-2016, 10 Celsius degrees for 79.5 hours between 19-AUG-2016 and 22-AUG-2016, 9 Celsius degrees for 22 hours between 23-AUG-2016 and 24-AUG-2016, 1 Celsius degree for 71 hours between 26-AUG-2016 and 29-AUG-2016, 1 Celsius degree for 53 hours between 30-AUG-2016 and 31-AUG-2016, 0 Celsius degrees for 168 hours between 15-SEP-2016 and 21-SEP-2016, 0 Celsius degrees for 218 hours between 22-SEP-2016 and 30-SEP-2016 and 1 Celsius degree for 92 hours between 01-OCT-2016 and 05-OCT-2016 (summary time of excursions 1500.25 hours). There were no adverse effects reported. There were no data logger and no prior excursions. This is one of several reports received from the same reporter. Follow-up information was received on 16-DEC-2016: all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA013015: US-009507513-1610USA013016: US-009507513-1610USA013017: US-009507513-1610USA013018: US-009507513-1610USA013019: US-009507513-1610USA013020: US-009507513-1610USA013021: MERCK 1610USA004014:Mfr number.
I started feeling more and more fatigue. It was time for a routine blood work. They checked my sedate rate, which is over 100. Which is very high. My doctor diagnosed me with polymyalgia rheumatica. I also had body aches, should, and hip pain. These symptoms are still ongoing. My doctor thinks this is from the vaccine.
About 1 wk after 1st GARDASIL, my daughter began having headaches, nausea and began passing out. Began having trouble breathing. Pediatrician referred her to cardiologist. Tilt table test were done. BP problems were noted. She has been on medications since. 3/3/09-records received presented with C/O fainting spells 2-3 times per day no LOC. Assessment:chronic fainting spells, chronic dizziness. 7/16/08 C/O abdominal pain watery diarrhea. Positive ill contact. 8/22/08-C/O SOB. History of episodic SOB at school day of visit. C/O body aches. Bronchial asthma. 10/17/08 chest pain with tenderness center or chest. Assessment costochondritis. 1/22/09-persistent headache. 3/9/09-consultant records received for DOS 5/14/08-seen for C/O dizziness and fainting for one month. All occur with position changes. C/O fatigue. Heart rate mildy accelerated prior to fainting and feels dizzy and wobbly.  Impression:mostly likely secondary to neurocardigenic syndrome. Office visit 6/4/08-Continues to faint on daily basis and having difficulty breathing when running. Impression strong vasodilatory component. Neurocardiogenic syncope. Recommend volume loading and salt in diet. Office visit 8/27/08-continues to have dyspnea mostly during PE at school, feels like she cannot breathe, loses breath,loses balance and nearly faints. C/O shortness of breath rather than syncope.
dx w/acute transverse myelitis-hosp from 9JAN97-17JAN97 then transported to a rehab facility w/lower extremities paraplegic & numbness up to T4/t% level;
Red itchy spots on neck and chest.   Took antihistamine for 2 days.  Tongue blisters on both side and felt like it was burned.   Resolved in 3 -4 days Dry mouth.  Resolved in 3-4 days
This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (Felt her fibromyalgia (musculoskeletal pain) more amplified than before taking vaccine) and POOR QUALITY SLEEP (She is also experiencing poorer sleep quality) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 vaccination. Concurrent medical conditions included Fibromyalgia. In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FIBROMYALGIA (Felt her fibromyalgia (musculoskeletal pain) more amplified than before taking vaccine) and POOR QUALITY SLEEP (She is also experiencing poorer sleep quality). At the time of the report, FIBROMYALGIA (Felt her fibromyalgia (musculoskeletal pain) more amplified than before taking vaccine) and POOR QUALITY SLEEP (She is also experiencing poorer sleep quality) outcome was unknown. No concomitant medication were provided. No treatment details were provided. It was reported that the patient felt her fibromyalgia more amplified than before taking vaccine and it happened more frequently when the weather changes. Company comment: This case concerns a female patient of an unknown age with relevant medical history of Fibromyalgia, who experienced non-serious unexpected worsening of Fibromyalgia and poorer sleep quality after the second dose of mRNA-1273. The events occurred in an unknown temporal relationship to vaccine administration. Treatment information was not disclosed and outcome is unknown. The nature of underlying Fibromyalgia remains a major confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This case concerns a female patient of an unknown age with relevant medical history of Fibromyalgia, who experienced non-serious unexpected worsening of Fibromyalgia and poorer sleep quality after the second dose of mRNA-1273. The events occurred in an unknown temporal relationship to vaccine administration. Treatment information was not disclosed and outcome is unknown. The nature of underlying Fibromyalgia remains a major confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.