chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 14 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 01-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # N000326, expiry date 14-DEC-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766: US-009507513-1709USA012764.
Patient was given an adult dose of Hep B instead of the Pediatric dose.  Patient was notified and assessed and reports no adverse events.
7 minutes after injection was administered patient developed hives and a pink rash on the injeciton site arm.  The provider was notified.  She checked his lungs and throat.  He was not experiencing any breathing difficulties or cough.  No swelling of the throat or limbs.  He was administered a dose of benadryl.  He was kept in the clinic.  The symptoms started to subside about 30 minutes after benadryl administration.
Pt reports arm was sore, swollen and red beginning Friday eve and continued throughout the weekend. Symptoms resolved by Monday took naproxen for the discomfort.
I got body-ache/Hurts like heck; Fever; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (received 1st dose of Shingles vaccine and it hurts like heck refer case US2022AMR081826).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced general body pain and fever. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the general body pain and fever were recovered/resolved.   It was unknown if the reporter considered the general body pain and fever to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR081826   Additional Information: GSK receipt date: 18-May-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient self reported this case. The patient received the second shingles dose and it hurts like hell. The patient got body ache and fever. The patient stated that next day like nothing happened. Additional Supportive Information: Follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR081826:same patient, 1st dose
allergic reaction from the waist down that worsens over time.; after vaccination 4 hours later he felt headache; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (allergic reaction from the waist down that worsens over time.) and HEADACHE (after vaccination 4 hours later he felt headache) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN for Headache.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced ALLERGY TO VACCINE (allergic reaction from the waist down that worsens over time.) and HEADACHE (after vaccination 4 hours later he felt headache). At the time of the report, ALLERGY TO VACCINE (allergic reaction from the waist down that worsens over time.) and HEADACHE (after vaccination 4 hours later he felt headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided.
He has a bad hip and needs to take Tylenol before he rides the bike; This is a spontaneous report received from a contactable consumer (Patient) via a Pfizer-sponsored program. CEP ID: 002191  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date after vaccination, the patient had a bad hip and needs to take Tylenol before he rides the bike. Patient likes to ride his stationary bike. Patient read online that before getting the COVID-19 vaccine that patients were not supposed to take Tylenol or ibuprofen and wanted to know if he was okay to take the Tylenol now to ride his back or does he need to wait until the shots are over. Patient has not taken Tylenol and would not like to do a safety report. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
approx 5 mins p/recvd vax pt became faint, pale w/tonic rigidity of arms & upper body; pt was unconscious approx 20 sec & incont of urine; responded to ammonia inhalant; BP 118/68 on release;
pt recvd vax 10AM 13NOV95 &  4PM fever started 9PM t103.3-4AM t104.7; given APAP & baths;very lethargic; no voiding for 12 hrs;
Intense chills and shivering that awakened me from sleep, fever reaching 102, body aches, nausea dizziness headache for 4 continuous days post injection
1-5 days swelling and rash, pain in arm at injection side Day 3-4 Throbbing leg - felt artery flutter. 1-12 days recurring headache 3-18 days pain in shoulder and armpit near injection site Day 12-18 swelling in hand Day 2-18 - extreme fatigue, lack of energy Day 2-18 - higher blood pressure Day 4-18 ? Nausea and forgetfulness
Shortly after her vaccine, she reported feeling chest tightness and maybe heavier breathing.   It persisted for at least 15 minutes and mostly subsided. At the same time, she said she had numbness in both of her cheeks and a hot feeling. That sensation migrated up towards her nose and was more mild, but not gone, by the time we handed her over to EMS.
Started having heart palpitations the day following becoming fully vaccinated. Received medical care on 3/30 I believe where a blood test and  EKG were done and both came back normal. On 4/2 (not 100% sure on date) it was recommended that I get a heart monitor to wear for two weeks. Results from the heart monitor basically just showed that the palpitations occurred but couldn?t find relation to anything. The palpitations happened very frequently at the start and then in the coming months slowed down. Now I probably only get them once a week maybe, but had never experienced them prior to becoming fully vaccinated.
On Day 2 after vaccine- a rash had developed across my upper arm where the vaccine had been given. The rash site is red, hard and painful to the touch.
High fever (highest was 104.1), cough, fatigue, chills, tiredness, large rash at injection site covering half of upper arm. For vaccine 1, I had a small rash, but this one is very large. The rash is painful, hot, and itchy. I?ve taken Tylenol and Advil. Today is 6/15 and I still don?t feel 100% back to normal and my vaccination was on 6/10.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
13y/o male received Pfizer bivalent booster on 11/29/22 minutes after pt felt faint, clammy, and cyanosis. Provider notified and code blue called. Oxygen and epi pen was administered by provider FNP. Patient seemed to be alert once epi was administered. 911 called once ambulance arrived pt was assessed by EMT then taken to hospital
pt recv vax 5NOV96 & devel a gen rash which spread over several days into an irregular blotching rash on extremities;tx w/pred & sx resolved;
Patient started feeling dizzy 29 minutes after vaccination.  Patient states she has a heart condition.  Vitals were taken:  BP-142/92, O2-98%, Pulse-82, respiration 28.  Patient was given water and monitored additional 15 minutes.  Patient felt better and was cleared.  Patient was advised to see her PCP.
I got the shot that morning and by that evening my arm was sore, I thought I was just being a baby. I woke up and I couldn't even move my entire arm including my fingers. On Monday I had to go to emergency room and they diagnosed me with a frozen shoulder. They put my arm in a sling. On Feb 22 I started physical therapy, at this point I could only lift my arm to a 30 degree angle. I went to pysical therapy 2 times a week till March 22nd. It also hurt like the dickens.
Patient fainted, fell to floor, no injuries, was surprised he was on floor.  Stated he had walking vertigo and had no drank any liquid that day. sat patient in chair gave water and he felt much much better.  Patient departed on his own after a time, said he was doing fine.
Patient reported swelling/pain on Tuesday 3/26 to MD. Vaccines TDaP and PNEUMOVAX were administered by this nurse on Monday 3/25. MD notified this nurse Wed 3/27/19. Note vaccines administered on left arm and patient reported left arm pain/swelling. He went to ER 3/26 and was given IV Abx.
10 days after taking second shot(4/2/21)   developed a yeast infection and rash on left side of face
MRI did reveal that there was some bleeding in patient's brain; couldn't stood up; coordination with patient's left hand somehow degraded and patient was actually unable to tie the shoe properly; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 23Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included cerebral amyloid angioplasty. The patient's concomitant medications were not reported. When the patient went to bed that evening (unspecified date), the patient felt fine and slept well. The patient got up the next morning and couldn't stood up with the patient's shoe on and the patient tried to tie the shoe and found out that the patient's coordination with the patient's left hand somehow degraded, and the patient was actually unable to tie the shoe properly. The patient explained this symptom to the neurologist and the neurologist said, it would be good for the patient to go to the emergency room right away. The patient went to the emergency room and got an MRI. They kept the patient there for 2 to 3 days and "that's pretty much over I'm fine again" as stated by the patient, but the coincidence is several of the patient's friends and the patient have trouble just a bit (further clarification unknown). The patient had this issue with left hand. The patient was injected in the left arm. The MRI did reveal that there was some bleeding in patient's brain. It got better, it hasn't pass but it struck the patient as a potential effect of some ingredient may be in the vaccine. The patient asked if there is anything in the vaccine that one with Cerebral Angioplasty should avoid because of potential blood thinning impact of one of the ingredients. The patient was recovering from some bleeding in patient's brain. Outcome of the rest of the events was unknown.  Information on the lot/batch number has been requested.
~15 hours of fever with peak temperature of 101.5 degrees Headache, shivering, muscle soreness, soreness and redness around shot area.
Swelling, Redness, Excessive fussiness, fever, and pain severe enough to affect mobility.
Pt recv vax on 10/15/97; subsequently pt exp 2 in area of redness at vax site.
Yesterday, 4/3/21 started as a pink pin prick rash by injection site.  Today, 4/4/21 a big red swollen area by injection site.
Extreme muscle pain/aches particularly in back. Chills. Swelling, redness, and very sore at injection site.
Patient felt warm this AM and had a brief episode of stiffening then jerking then somnolence, seizure lasted 30 seconds.  Mom gave albuterol vin neb and ibuprofen prior to paramedics arriving.   1996 in EOC PM positive febute SZ, chest x-ray negative.
"About an hour after receiving the Pfizer covid vaccine, I developed a red itchy area on my opposite scapula/back. It went away after roughly 30min and then reappeared on a small part of my neck. I went to employee health, notified them, and was given a Claritin. While waiting for it to work, the top of my head and bottom of my feet itches for just a minute. The employee health nurse thought my reaction could have been from the latex on the top of the vial. In the past I've gotten mild localized rashes from latex bandaids. Perhaps if the vial was made of something other than latex that may have prevented or minimized my reaction. Or reaction could be from something else, as I've never gotten this reaction from other vaccines before. However, I much prefer this reaction to getting covid and it's side effects, and am thankful to have received this vaccine."
Patient developed a fever, crankiness and body redness that lasted on and off for several days. He also developed redness and swelling at the site of the injection on his left upper arm.
STARTED FEELING CHILLS, BODY ACHES, HEADACHE, AND NAUSEA. LOSS OF APPETITE. TOOK TYLENOL EVERY 4 HRS AND PLENTY FLUIDS.
Severe headache, Fever (101.5), Chills, Muscles aches.  Symptoms lasted for 2 days and were significant .   This vaciine cause the most severe sickness I have had in several years.   I am reporting this because I think it is important to have accurate data on side effects.
Initial misuse report received from a health care professional on 16 October 2013 and at GPV on 21 March 2014. A 17-year-old 06 months old patient of unknown gender had received FLUZONE ID. The patient received FLUZONE at an incorrect age. No adverse event was reported. The list of documents held by sender: none
Patient stated that she has had a sore arm since receiving her vaccination. She came in a week after the vaccination stating that her arm was sore. I assured her that it should get better and if not to contact her PCP and let us know. She called back this week and informed us that she went to Urgent Care to treat the soreness in the arm which patient said MD didn't believe it was from the shot. Patient claims going to orthopedic specialist and will get an MRI. Specialist also doesn't believe it is from the shot but patient claims it is.
nerve pain; increased heart rate; dizzy, drunk like feeling; a feeling of heaviness in her body; feeling hot with no fever; having trouble standing; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (nerve pain), HEART RATE INCREASED (increased heart rate), DIZZINESS (dizzy, drunk like feeling), MUSCULOSKELETAL DISCOMFORT (a feeling of heaviness in her body) and FEELING HOT (feeling hot with no fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history was reported.  Concomitant products included ATENOLOL and SIMVASTATIN for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced NEURALGIA (nerve pain), HEART RATE INCREASED (increased heart rate), DIZZINESS (dizzy, drunk like feeling), MUSCULOSKELETAL DISCOMFORT (a feeling of heaviness in her body), FEELING HOT (feeling hot with no fever), MOBILITY DECREASED (having trouble standing) and VACCINATION SITE PAIN (injection site pain). At the time of the report, NEURALGIA (nerve pain), HEART RATE INCREASED (increased heart rate), DIZZINESS (dizzy, drunk like feeling), MUSCULOSKELETAL DISCOMFORT (a feeling of heaviness in her body), FEELING HOT (feeling hot with no fever), MOBILITY DECREASED (having trouble standing) and VACCINATION SITE PAIN (injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.
PATIENT DEVELOPED PALMAR FIBROMATOSIS STARTING AFTER THE IMMUNIZATION, NOT PREVIOUSLY PRESENT
Initial report received from a non-healthcare professional on 10-Oct-2013. This case is part of 1 cluster cases and is linked to case number 2013SA103906 (same reporter, events after FLUZONE QIV, lot number: U4772AA). A patient whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE QIV (Lot number: U4772AA, expiration date: 30-Jun-2014) intramuscular route (site of vaccination was not reported) on 08-Oct-2013. On 09-Oct-2013, two patients had shaking, chills and fever. One of these two patients had a temp of 103F. List of documents held by sender: none.
headache on the right side back of the head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache on the right side back of the head) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ROSUVASTATIN CALCIUM (CRESTOR), NIFEDIPINE, VITAMIN D3 and OLMESARTAN MEDOXOMIL for an unknown indication.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced HEADACHE (headache on the right side back of the head). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 15-Mar-2021 for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache on the right side back of the head) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This spontaneous report as received from a healthcare worker refers to a 12 months old male patient with a history of gastroesophageal reflux and no drug allergies. The patient was vaccinated SC, with MMR II (lot # was reported as 0398AA), 0.5ml on 27-JUL-2012. Suspect therapy on the same day included VARIVAX (Merck). Concomitant medications on the same day included HAVRIX, PREVNAR. On 28-JUL-2012 the patient developed fever and measles like rash. The patient had visit the office for medical attention. No lab test was done. No treatment was given. The reporter stated that the patient had fever for 3 days and the rash for 5 days. The outcome of the events was unknown. Additional information has been requested.
After roughly 15 hours I woke up with a fever, which followed by severe chills, sweating, and muscle aches. Was not ale to sleep the rest of the night. After around 8 hours the symptoms subsided, but still feel flu-like and have a low fever more than 24 hours after the shot.
Reporting administration error as per Agency.  We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised that the expiration dates were deemed viable at the time of vaccine administration. Pfizer vaccine vials only include manufacturer dates on the box and vials. Therefore, we contacted Pfizer to obtained expiration dates directly from them.  No adverse reactions were reported from the patient at the time of vaccination. No adverse reactions were reported since the administration of vaccination
Local Site reaction, about The Size of a small orange. Red, Swollen, Hot To Touch, Itchy, by Touch Their is a Nodule, (Large Knot). Onset occurred that evening, was sore. Now just itchy and Red and swollen. Will Take Benadryl and Ibuprofen persists will see MD.
Information has been received from a pharmacist concerning a patient of unknown age and gender. On 24-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose and route not provided). On 04-DEC-2015, the patient inadvertently received second dose of ZOSTAVAX (extra dose administered) (dose, and route not provided). No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from an healthcare worker refers to unspecified patients of unknown ages. Since an unknown date in July 2014, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot#, strength, dosage, frequency and route unknown). No adverse effects were reported on the reporting time. This is one of several reports received from the same reporter. Additional information has been requested.
SMV: Pfizer Dose 1 (EN6206, exp 6/30/2021) on 3/25/2021  SMV: Pfizer Dose 2 (ER8731, exp 8/31/2021) on 4/15/2021  Symptom onset  06/10/2021 (same day as admission to inpatient) of sore throat, fatigue, cough, nausea/vomitting, and headache.   Hospital records request shows treatment for DM2 uncontrolled with hyperglycemia, AKI, Dehydration, and uncontrolled hypertension.  COVID Pneumonia listed as active diagnosis: 1 dose of dexamethasone on June 11, 2021 and then dexamethasone was discontinued. Patient is also not on remdesivir. Patient denies shortness of breath or cough.
Approx. 24 hr after vaccination, developed congested cough, sore throat (mild) and mild ear ache; followed by profound bone pain in long bones (humerus x 2 femurs x 2 tibias x 2).
This spontaneous report as received from a pharmacist refers to an adult patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. In September 2016 (reported as "a month ago on an unspecified date"), the patient was vaccinated with a dose of PROQUAD injection (dose, dose number, route of administration, injection site, lot number and expiration date were not provided). There were no concomitant medications reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected because the reporter refused additional contact.
Fever to 102, fussiness, dec appetite, head congestion, gassy & jerking for four days; tx-APAP & Naldacon EX
Patient began experiencing tingling in his thigh area and has developed into progressive neuropathic pain in his arms and legs.