chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache Neck pain Chills Fever (101.8 degrees, taken orally) Myalgia Dizziness Muffled hearing in left ear (injection side) -- intermittent Palpitations Arm pain (left arm/injection side) Itching at injection site Diarrhea
Dizziness, Headache, pain at injection site that traveled up the left of her neck to her left jaw. Narrative:
low grade fever; aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever) and MYALGIA (aches) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (low grade fever) and MYALGIA (aches). At the time of the report, PYREXIA (low grade fever) and MYALGIA (aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by the reporter. No concomitant medication reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Nov 22, 19 Pt c/o pain & bruising RT deltoid Nov 25th, 19. OVisit. Bruise & 2 smaller bruises Rt deltoid, pain @ bruise areas. Steroid Injection Rt shoulder Nov 14th
Pt began to have swelling, which parents described as approximately 3.5in, tactile warmth & mild pain when touched to his left thigh. Injections were given on 8/1/18, parent called office on 8/3. Nurse advised pt's mother to apply cold compress as needed & have him seen if it worsens or if she becomes concerned. Nurse called to check on pt but got no answer. Voicemail was left.
Headache, Arthralgia, Fever, FATIGUE, CHILLS, PAIN/SELL INJ SITE Narrative:
Information has been received from a licensed practical nurse concerning a patient who on an unspecified date was vaccinated with a first dose of zoster vaccine live (Oka/Merck). Subsequently, the patient came down with a case of shingles. Unspecified medical attention was sought. The patient's outcome was no provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Patient was working in the traffic area of the parking lot. The patient was exiting the area after the 15 min observation period. She reported no symptoms or complications prior to leaving the area and no usual behavior was noted at this time. Patient was accompanied by her husband and son. Near the parking lot the patient was witnessed losing consciousness and falling to the ground. Patient immediately assisted the patient and also called for assistance. I was notified immediately and myself, the paramedics on sight, and NP responded to the patient incident. The patient was diaphoretic and had abnormal vital signs that were repeated multiple times. The set I obtained were 117 heart rate, 99% oxygen on room air, 167/94, 225/112, both taken lying down. Patient complained of severe headache, blurry vision, tinnitus, and dizziness over the past 2 days prior to days. Patient reports having only one medical condition, psoriasis, and takes a cream for it, but also reports she has not seen a doctor in "many years". No stroke symptoms were observed.
shaking/chills and fever (up to 100 degrees), headache, nausea, upset stomach.  Resolved slowly but within 24 hours.
Patient received under diluted dose of pfizer 5-11 vaccine. Had vomiting after vaccine and received Zofran.
Injection site is sore with a red streak originating from injection site one and one half inches in length.
I received the Bivalent Pfizer Omicron booster and had a very back reaction. I feel it was an allergic reaction. Fever, swelling in my head to the point of temporarily looking hearing in my left ear (side of body I had vaccine shot). Also, on Friday could not move with muscle aches and cramping in my legs. I did not have a bad reaction to the original Pfizer Covid vaccine, nor subsequent booster, so had not anticipated an issue with this one. It was bad and only relief cam from taking Benadryl, which helped to reduce swelling way up in my head (not sinuses). Helped with hearing too. However, I still am having some difficulty with my left ear. I will be seeing my regular physician tomorrow and will inform him as well. Wanted to report to FDA too.
Caller tested positive on 05Jan2021.; Caller tested positive on 05Jan2021.; Caller tested positive on 05Jan2021.; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received the first dose of the COVID 19 vaccine on 29Dec2020, second dose is due on 20Jan2021. Patient tested positive on 05Jan2021. Patient wanted to know if he should get the second shot and if he chooses to wait the 90 days, would he need to start over. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05Jan2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (tested positive) with BNT162b2 can not be completely excluded.
I am running a temperature of, it was up to 102 yesterday, but coming down; also had headache; still feel tired today; This is a spontaneous report from a contactable consumer (patient). A 65-year-old patient received first dose of BNT162B2 (), via an unspecified route of administration on 18Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced i am running a temperature of, it was up to 102 yesterday, but coming down, also had headache, still feel tired today on an unspecified date. The report received as, side effects started Monday morning and I am running a temperature of, it was up to 102 yesterday, but coming down. Left work early yesterday my temperature was 101 and went up to 102 later. This morning it's coming down, also had headache, it was tolerable no aspirin took nothing, tired, still feel tired today, makes me apprehensive about getting the second dose. Caller states as, I had covid virus, March of 2020, I was one of the early ones, never got tested though, so it's not on record, but I had every symptom but the breathing. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit and body temperature: 101 fahrenheit on an unknown date. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Severe period cramps. I have PCOS so I know what bad cramps feel like, but these are on another level.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unknown age, gender and race/ethnicity received a single dose of PREVNAR 13 for immunization on an unknown date. Medical history and concomitant medications were not reported. On an unknown date, the patient had cellulitis at injection site. Outcome was unknown.
pt recvd vax 12JUL95 & exp diff breathing w/chest tightness,dry cough,& wheezing;addl beginning was achy all over & had a fever of 102.7;seen by MD who treated w/erythromycin & ventolin;
Patient started feeling stinging and burning feeling in her body immediately after the vaccination; Patient started feeling stinging and burning feeling in her body immediately after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Patient started feeling stinging and burning feeling in her body immediately after the vaccination) and BURNING SENSATION (Patient started feeling stinging and burning feeling in her body immediately after the vaccination) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN (Patient started feeling stinging and burning feeling in her body immediately after the vaccination) and BURNING SENSATION (Patient started feeling stinging and burning feeling in her body immediately after the vaccination). At the time of the report, PAIN (Patient started feeling stinging and burning feeling in her body immediately after the vaccination) and BURNING SENSATION (Patient started feeling stinging and burning feeling in her body immediately after the vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.
started feeling like my throat was closing up; hard time swallowing; Got shaky; heart racing; felt like I was in a tunnel; Every inch of my body is screaming; This spontaneous case was reported by an other and describes the occurrence of OROPHARYNGEAL DISCOMFORT (started feeling like my throat was closing up), DYSPHAGIA (hard time swallowing), TREMOR (Got shaky), PALPITATIONS (heart racing) and FEELING ABNORMAL (felt like I was in a tunnel) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL DISCOMFORT (started feeling like my throat was closing up), DYSPHAGIA (hard time swallowing), TREMOR (Got shaky), PALPITATIONS (heart racing), FEELING ABNORMAL (felt like I was in a tunnel) and ILL-DEFINED DISORDER (Every inch of my body is screaming). At the time of the report, OROPHARYNGEAL DISCOMFORT (started feeling like my throat was closing up), DYSPHAGIA (hard time swallowing), TREMOR (Got shaky), PALPITATIONS (heart racing), FEELING ABNORMAL (felt like I was in a tunnel) and ILL-DEFINED DISORDER (Every inch of my body is screaming) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a physician referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of improperly stored MMR II (lot # K016154, expiration date 24-SEP-2016, subcutaneous). No adverse effects were reported. Additional information has been requested.
After receiving my shot on 4/22 I started getting singular hive like bumps on my legs and arms, thinking they were big bites I ignored them until they began to form a sort of rash covering my left hand and sporadically on the left side of my body. When the rash formed I went to urgent care on the morning of 5/2, at the urgent care the doctor prescribed me a steroid to help calm the rash down, at this time I was also taking benadryl to help. The next morning, 5/3, Around 5 in the morning my mother rushed me to the ER where they gave me an IV of benadryl, and steroids, and they also have me a shot of epinephrine. This helped the reaction, but I was referred to a dermatologist to see if they could figure out the cause of the ?rash? they did a biopsy and concluded that there was a hypersensitivity reaction  such as urticaria  and drug eruption.
Patient had never felt better and then suddenly died; Initial information was received on 12-Oct-2020 regarding an unsolicited valid serious case received from a consumer/ non-healthcare professional (patient's spouse) via public post on the Sanofi flu shot campaign via Social Media.  This case involves male patient (age not reported) who had never felt better and then suddenly died (malaise), while he received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious adverse event as the patient had never felt better and then suddenly died (malaise) on an unknown latency following the administration of INFLUENZA VACCINE. This event was was leading to death.  Case details: Product name was not provided, since this is a public post on the Sanofi flu shot campaign, the Race for 200M it was assuming that the consumer was referring to the Sanofi flu vaccine. The reporter commented on social media that 'my husband had never felt better then suddenly died'  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  The outcome was reported as fatal as the patient suddenly died due to suspect vaccine on an unknown date  It is unknown if an autopsy was done and the cause of death was captured as malaise.  Information on the batch number was requested.; Sender's Comments: A case was reported from Social Media, which involves male patient of unknown age who had felt unwell and then suddenly died following the administration of INFLUENZA VACCINE (unknown manufacturer). The time to onset was unknown. Additional information of past medical treatments, concomitant therapies, past vaccination and tolerance, allergic history, concurrent conditions, laboratory data and autopsy results is needed for complete assessment of the case. Based upon the reported information the role of the suspect product cannot be assessed. Missing data needed for further assessment of the case.; Reported Cause(s) of Death: Patient had never felt better and then suddenly died
No additional AE; Caller reported that M-M-R II, ROTATEQ and VAQTA that underwent temperature excursions were administered/VAQTA - ED: 6/1/2022; This spontaneous report was received from a pharmacist and refers to a patient of unknown age ang gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 01-JUN-2022, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, unk, lot #W002889, expiration date: 06-MAR-2023, administered for prophylaxis (strength, anatomical location and route of administration were not provided).  The vaccine was stored at the temperature that was reported as above 47 degrees of Fahrenheit (46.9 F) for 25 minutes. There was a previous temperature excursion reported as above 47 F (47.2 F) for 25 minutes.  No additional adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2206USA000873: US-009507513-2206USA005640:
I woke up the next day after the shot with 3 swollen nodes on my shoulder blade.. achey and with a low grade fever arm hurts  ... was dizzy and don't feel good all..0
still ended up with 2 strains of the flu; Initial information was received on 19-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional.  This case involves an unknown age/gender patient who still ended up with 2 strains of the flu after being vaccinated with influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (lot number, route, administration site formulation, expiry date: Unknown) for flu (influenza).  On an unknown date the patient developed a serious still ended up with 2 strains of the flu (influenza) (unknown latency) following the administration of influenza vaccine.   No lab data reported.  Action taken: unknown.  It was not reported if the patient received a corrective treatment for the event (still ended up with 2 strains of the flu).  Outcome was Unknown for the event still ended up with 2 strains of the flu.  Seriousness criteria: The patient was hospitalized for this event.; Sender's Comments: Sanofi company comment dated 22-Dec-2022: This case involves an unknown age/gender patient who still ended up with 2 strains of the flu after being vaccinated with influenza vaccine. Furthermore, information regarding concomitants excluding other predisposing etiologies, intervention (if any), medical history, corrective treatment/medical management, family history, would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
pt c/o pain in rt upper arm & axilla;Ibuprofen & hot packs;
Swelling to B/L hands, itching and rash to right hand.  Patient advised to use OTC antihistamine and follow up with PCP.
Patient stated she had a metallic taste in her mouth post injection. She drank gingerale and the taste subsided
Pt suffered appendicitis about 10 days after 1st dose and had to have appendix removed.  Doctors did not attribute it to vaccine but pt wanted to report anyways.
No immediate adverse events other than usual sore arm, aches for 2 days.  In May of 2021 (4 months post 2 vaccines) while at my annual physical exam an EKG was performed due to my complaints of palpitations.   It showed a Left Bundle Branch Block which was not present on EKG done 2 years before.  I realize this may not be related to the vaccine at all, but felt I should report it in case others were experiencing the same thing.
On 5/14, Saturday, I had a pretty bad cough, classic tickle in the back of my throat were I could not clear my throat. I called the doctor on Sunday and I did a home test and it came out positive before I even put the drops on it. The doctor  prescribed prednisone. I had no fever, I still have my taste and smell, and I am a little tired. I have been on prednisone and I will finish up on Sunday, 5/22/2022. I took a covid-19 today, 05/20/2022 and it was positive. The cough is mostly gone, my sinuses are a little stuffy, other than that, I have good appetite, nothing else out of the ordinary.
I had had joint pain before the vaccines but it wasn't anything that got in the way of life. After the vaccination, I couldn't,  my joints were hurting so bad. It was hard to walk. In the morning, I was super stiff. I had extreme joint pain. I had to go to the doctor the week after March 16th. She had me go to a Rheumatologist, we ruled out a lot of things. I have a possibility of Psoriatic Arthritis. I currently still have a lot of joint pain that I did not have before the vaccination. All my blood results came back okay. I was put on meloxicam, an anti-inflammatory. I do get a little relief from it when I take it as needed. The pain doesn't disappear, it's always there, but it makes it better. But if don't take it, the pain does get worse.
Reported double vision, dizziness, frontal headache "8" on a 10.
Increased Heart Rate 130BPM; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Increased Heart Rate 130BPM) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced TACHYCARDIA (Increased Heart Rate 130BPM). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Mar-2021, TACHYCARDIA (Increased Heart Rate 130BPM) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Heart rate: 130 130 bpm.. On 08-Mar-2021, Heart rate: normal.         Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication were reported.  All tests were reported normal.  The patient doesn't know the name of the second medicine received for treatment
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN (in 2weeks). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of covid-19. Treatment start date: 23Apr2022, Treatment stop date: 28Apr2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After second dose, had the typical feeling like the flu, but lymph nodes were swollen. The flu symptoms passed, but continued to have problems with lymph nodes. Fatigue set in just after flu symptoms, have never recovered. In June, I started having pain in my upper maxillary. Saw my dentist, who sent me to a dental surgeon. They determined that it was wire from a jaw surgery 30 years ago. They removed the wire, but all of the other wires are giving me pain, and may need to be removed. They had not bothered me prior to the vaccine. Mental health has also declined and not recovered. My medications are now higher than pre vaccine. Fatigue is still a major problem.
Acute urticaria all over the body swollen 4" round shot site swollen, red, tender Allegra 180 mg PO QD Zyrtec 10mg one PO QD Medrol DosPak
On 08/25/2000 the patient began to develop a rash. The patient's mother reports that she had a lot of pain in the area of the lesions. On 08/31/2000 the patient was diagnosed with herpes zoster. The lesions are on the right side of the patient's chest and extend to the right back area. The patient has a low grade fever, 99-100F, a reddened throat, and a tiny spot above one of her eyelids. The patient was treated with acyclovir. It was noted that the patient has no known recent exposure to varicella or shingles. Follow up information received on 08/31/2000 from a NP indicated that the patient did not experience a post vaccination rash at the site of the injection. The patient's lesions were described as maculopapular herpetic lesions, which were erythematous and too numerous to count. It was noted that systemic symptoms included: pharyngitis, mild anorexia, mild malaise, neuralgia at the dermatan. The RN reported that "at this time the patient is recovering". Additional information has been requested.