chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu; Felt bad/didn't feel good; Chills; This is a spontaneous case, initially received from other non-health professional (consumer) on 28-Nov-2018, concerning a 77-year-old, elderly female patient.  On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for an unknown indication.  On an unspecified date, within 24 hours after vaccination, the patient felt bad (did not feel good) for 1-2 days. In addition, the patient also experienced chills and got flu.  The outcome of the events was recovered within 1 to 2 days.  Follow up received from other non-health professional on 11-Dec-2018: The reporter stated that, she did not remember the name of flu vaccine. The patient experienced the events within 24 hrs after the vaccination and recovered from the events in 1 to 2 days. The as determined causality of the events, narrative and case comment were amended accordingly.; Reporter's Comments: A 77-year-old female patient experienced symptoms of felt bad, chills and reported to have got flu, within 24 hours after receipt of INN flu vaccine. Considering the fact that influenza vaccine needs minimum 2-3 weeks to provide immune protection against influenza infection, vaccination failure and causal role of suspect vaccine for the event flu can be ruled out. Hence, the company assessed the causality of event flu as not related to suspect vaccine. The company assessed the case as serious (medically significant).
pt recv vax 24MAy95 & 16DEC97 pt devel chickenpox lesions;pt required a visit to MD office on 18DEC97;pt recovered;
had reactions to second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had reactions to second dose) in a patient of an unknown age and gender 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 VACCINATION COMPLICATION (had reactions to second dose). At the time of the report, VACCINATION COMPLICATION (had reactions to second dose) outcome was unknown.            No concomitant medications were reported. No treatment details was reported.
Pt was admitted to hospital with a positive COVID test on 1/21 and transferred to another hospital on 1/25.  Prior to arrival the pt had 6 days of worsening cough, fever, extreme fatigue, and worsening shortness of breath.
I came down with COVID-19 in December 2020, and I have been continuing to have my health decreased since then. Polyps had formed six months after having COVID-19. I have been checked for cancerous polyps however they came back negative. After my JJ vaccine I did start to notice that my health started to decrease more so and no improvement continued. After my Moderna Booster I have been experiencing more severe sinusitis and infections. And I was recently diagnosed with Lupus with a positive test recently as well as GERD. I have been on many antibiotics for multiple reasons and I did have a bout of Diverticulitis within the last two weeks. I am still experiencing any fatigue as well.
Headache, Myalgia, Fever, FATIGUE; CHILLS, BODY ACHES,RASH; INJECTION SITE PAIN AND SWELLING Narrative:  Other Relevant History:
On June 28th, I woke up at 3:45AM with extensive chest pains. I sat up in bed for quite some time hoping they would go away, but they did not. I moved myself to another bedroom in my house and eventually the pain subsided. I called and left a mychart message to my doctor in the morning. I spoke to a nurse and went over the situation with her. On 07/05, I had heart palpitations that lasted for 2 1/2 minutes. I went to an appointment on 07/07/2021. The PA advised that if this happens again, to go to the ER right away. PA thinks it could be Costochondritis or a coronary spasm. I have had two episodes that have occurred.
Injection given approximately 10:00 AM. Patient left clinic returned in 10 minutes (approximately 20 minutes post injection) crying, screaming, stating could not move arm. Intense pain. Grip ok, moving arm, denies finger tingling/pain, very small red mark at injection site. Complete recovery in 20 minutes.
Child received IPV 2 days ago Lt thigh (5/8 needle length) swelling Lt thigh x 1 day. No known trauma. Insect-bite before IPV. Rt thigh swollen slightly increase temp. mod. erythematous. Rt circumference thigh 5cm x 10cm above knee. Rt 19.5x 25cm. Lt 23x 26cm. Child walks without limp. Rt knee-not swollen. Motrin 100mg, 5mls, 5mls po q 5 x 5 days. L thigh swollen immunizations on 9/18/02. Start Keflex. Cellulitis, vaccine reaction.
Severe hives, beginning as streaks proximate to injection site (L shoulder), rapidly spread to torso, arms and neck.
i was given pfizer vaccine instead a shingles shot which is why i was at the pharmacy i already had the J & J shot in April they made a huge error  i became ill in the middle of the night nausea vomiting extremely achy
Hives, swelling of face, tongue, and throat, pain and stiffness in hands/wrists and feet/ankles, painful and difficulty swallowing. Treated with Benadryl, Zyrtec, and Motrin during first 48 hours.  Started oral steroids at 36 hours for residual facial swelling.
For 4 days I had symptoms similar to the symptoms I had 15 years ago with ehrlichiosis.  I could not keep my eyes open, slept around the clock, weak, brain fog and loss of appetite.  I have what?s called chronic lyme and I am able to manage it with a healthy lifestyle.  It seemed to rush back.  I am 5 days away from my vaccination and slowly regaining energy.
Patient was given the smallpox and Varicella vaccinations on 18 Aug 05. On 21 Aug 05 his daughter developed a rash on her back. On 24 Aug 05 she was seen by her primary care provider and felt to have Herpes Zoster. She was then seen on 25 Aug by Infectious Disease who felt her rash was consistent with Zoster. Testing was done including testing of the lesions.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 12Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2021 (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 01Apr2023 to 05Apr2023.  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-202300151489 same patient, different drug/AE;
"Upper right arm pain extending from shoulder down, bilateral leg weakness, numbness in feet, malaise, warmness of skin (low grade fever but temperature not taken). All symptoms starting on day of vaccine- 10/27/2009 and getting progressively worse each day" Saw her family health provider on 11/09/2009 and had lab work drawn. 11/30/2009 PCP visit 11/9/2009  and neuro consult for 11/11/2009. Dx viral syndrome, peripheral neuropathy Patient with c/o's LE weakness, numbness of feet, rt deltoid and shoulder pain.  Cipro rx'd for UTI Neuro consult: neuro exam did note decreased ankle jerks, did rx medrol dose pack and Lyrica scheduled  for NCV study
Pt vaccinated with PROHIBIT experienced febrile seizure. No allergies or problem w/other vaccines or hx of convulsion. Fine as of 12SEP90.
The Moderna COVID-19 Vaccine  A delayed Red Rash with slight itch and  warm to touch 3 x 5 inch overall on left arm at the injection site
Patient had a syncope and recovered in few seconds, emergency response team was called to make no other adverse reaction
Chicken pox. Prescribed Zovirax, Atarax, aveeno baths, Tylenol, calamine lotion.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 29-year-old female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because their facility was unable to download the digital data logger, they would need to treat the issue as a temperature excursion. The data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. It was also reported that no adverse reactions were reported by patient.  No treatment information was provided.   This case was linked to MOD-2022-501575 (Patient Link).
Patient inadvertently received vaccine after published expiration date. Moderna analyzed vaccine and advised batch/lot# 007B21A maintained activity needed to protect against COVID-19 on date of vaccine administration. Also patient did not call in to advise of adverse event. This is administrative error without adverse event.
bell's palsy or could of had a stroke; mouth drooping; speech was a little slurred; could not smile, could not open mouth to eat; right eye started tearing up and was watery; A spontaneous report  was received from a consumer concerning a 55 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Facial paralysis, Lacrimation increased, Dysarthria and Facial discomfort.  The patient's medical history was not provided. Relevant concomitant medications were not reported.   On 05-FEB-2021, prior to the onset of the events, the patient received their first dose of two planned dose of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection. On 05-FEB-2021, the patient experienced Lacrimation increased. On 06-FEB-2021, the patient experienced Facial paralysis (mouth drooping), Facial discomfort. On 08-FEB-2021, the patient experienced Facial paralysis. The patient reported that he went to the doctor who said it could be bell's palsy or could had a stroke, and recommend he go to hospital to have it checked. The Patient reported that he has not gone to the hospital at the time of this report.  No Laboratory details were provided. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  At the time of this report, the outcome of the event's Facial paralysis, Lacrimation increased, Dysarthria and Facial discomfort was considered as not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Ocular migraine occurred on 20april and then ongoing blurry vision in right eye. Improvement in vision but still blurry as of 22 April
This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 09-OCT-2017, the patient was vaccinated with improperly stored doses of VARIVAX lot # N012131, expiration date 17-APR-2019 (dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 degrees Fahrenheit and 17 degrees Fahrenheit for 3 hours and 40 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007766.
Information has been received from a woman in a physician's office concerning a female who on approximately 12/11/01 was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (lot #640577/0995L). The patient was well at the time of the vaccination. It was reported that the patient was previously vaccinated with pneumococcal vaccine polyvalent years ago (exact date and lot # unknown). Following the December 2001 vaccination the patient subsequently developed a severe reaction to the vaccine and on 12/12/01 was seen in her physician's office and was diagnosed with cellulitis. It was reported that the cellulitis went from her shoulder to her elbow in the injected arm. The patient was treated with unspecified oral antibiotics and subsequently recovered. The patient did not require hospitalization. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Dizzy, Headache, unsteady on feet, chest feels heavy, nauseated
Injection site sore but was expecting that. Over the next couple days it was still feeling warm and a lump started moving down my arm. Seemed to settle in and around bicep. Skin was warm and reddish. The muscle felt itchy and sore. My whole upper arm was swollen.  Have had 2 nose bleeds whether related or not, I do not know.
Right arm became very painful and unable to move due to the stiffness of the upper arm.  Could NOT use or lift arm at all for 24 hours.  At 10:30pm on the 13th, my husband and I decided to try and move my arm slowly up and down to help "loosen the stiffness" when my husband lifted my right arm to about shoulder height, the pain was so bad I fainted. I have never fainted before in my life.  I was out for about 2-3 minutes.
15 min post vaccination c/o generalized itching. 25  Benadryl given. Pt declined to stay for further eval or treatment.
A few days later had to go to ER because wound became infected, participant believe it was due to the vaccine. IV antibiotics was given and also steroids. Wound was extremely red.
22 year old patient received ACAM2000, Typhoid, and Hepatitis A vaccines on 11 March 2008.  He was found on follow-up lab testing to have developed Thrombocytopenia (last PLT 70K) after an initially normal PLT count of 170K before beginning the study.  6/24/08 Reviewed medical records of 4/15/2008. FINAL DX: thrombocytopenia Records reveal patient was in good health on day of vaccination.  Had 1-2 days of mild axillary pain s/p vaccinations.
Patient ( 82 yo female ) came in with daughter ( FT caretaker ) to receive second Moderna vaccine.  Patient received vaccine at around 945 am on 10/05/2021 and was instructed to wait at patient waiting area for 15 minutes.  Five minutes into the wait, daughter approached counseling window wanting to leave.  I explained that it was a good idea that she wait since we wanted to make sure that her mom did not have an adverse reaction.  The daughter went to shop and left the patient behind sitting in a mobile shopping cart.  Five minutes later (and about 10 minutes after receiving immunization), the patient drove up to the counseling window saying she felt she was going to faint.  I instructed a technician to go outside and watch the patient while I called the daughter.  The daughter picked up the phone and said she was walking back.  I hung up the phone and then pharmacy technician said patient reported wanting to faint and when I checked her she was shaking.  Patient said she wanted us to call emergency.  We called a code white.  The rx technician stayed with the patient while I called emergency.  A member of management came over and stayed with patient alongside technician.  I communicated to the member of management that the ambulance would be coming and someone should wait out by the front door to direct the paramedics.  She nodded and replied that she already had someone out by the front door.  The paramedics arrived shortly after.  Daughter came to talk to me and explained that she did not believe her mother's state was due to the vaccine; she stated that her mother had Alzheimer's and that she thinks she has been having seizures.  (On PQCF and during review all answers were NO).  The paramedics decided to take her to Hospital and daughter followed.  About five minutes after they exited, one of the paramedics came in and asked for patient name and date of birth.  I gave the information to the paramedic.
3 hours post vax, the pt's arm became sore and turned red with fever. She couldn't do anything with her left arm and didn't have any energy. She was very sick for 4 days.
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information was provided. She had her leg death 18 years ago. She was bipolar, never should had taken Zoloft in first place and she had never been suicidal with other drugs. She was on medication, and she was mentally stable and then took Chantix and cut herself 15 years ago. No treatment medication was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Started getting light spotting about 2 weeks before the time I would expect to get my period. This continued on and off, and then my actual period starting about October 25th. It is a lot heavier than usual - I soak through 3-4 extra heavy overnight pads a day, and there are many dime-to-quarter sized blood clots.   Also - I've had calf pain since the day after I got the booster and it hasn't stopped.  I did not experience any side effects after my last 2 doses of the vaccine to my knowledge.
Patient incorrectly received the orig. Pfizer vaccine INSTEAD of the intended vaccine---Pfizer Bi-valent!!!
Fatigue; drowsiness; This case was reported by a pharmacist via sales rep and described the occurrence of fatigue in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue and drowsiness. On an unknown date, the outcome of the fatigue and drowsiness were recovered/resolved.   It was unknown if the reporter considered the fatigue and drowsiness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient was approximately 60 years old at time of this report. At the time of receiving 2nd dose of Shingrix, the patient reported that, he experienced fatigue and drowsiness after vaccination with 1st dose for one to one and half days. The reporter did not consent to follow up.
I got COVID-19 on 12/28/2021 but did not receive treatment, just treated at home. I had swelling in my armpit after my vaccine. I could not lift my arm. I had fatigue and fell asleep after the vaccine. I got Pityriasis rosea on 02/15/2022. I was seen by urgent care and gave me a steroid and hydroxyzine but nothing helped. It took two months but I still have a patch on my ankle. 07/07/2022 my heart rate went up high and has been that way since. I had sinus tachycardia on 7/20/2022.
Vomiting and diarrhea x 3 days; Treatment: 1/2 oz. Pedialyte q 20-30 minutes as tolerated.
The first Moderna shot caused me to miss my next menstrual cycle, which had never happened to me prior to receiving the shot. In the week I received the 2nd shot on 3/13/21, I had uterine cramping that same day within a few hours of getting the shot. I also noticed a change to my cervical mucus during my ovulation cycle 2 weeks later. I then became pregnant the following month and was found to have a missed miscarriage at 6 weeks 1 day. It seems like their is a strong correlation between the side effects from the Moderna shot and the miscarriage.