chrisvoncsefalvay/vaers-outcomes huggingface dataset:
30min after my 2nd vaccine (moderna) I couldn't lift the injected arm. Then for 5+days my muscles and joints, basically my entire body, was in severe pain. It felt like my muscles were being twisted off my bones. I continuously had a high fever/sweats, or significant chills. Because of the severe pain, I couldn't sleep (get comfortable in general) and had insomnia for 2+ days. I had intense headaches, nausea throughout as well. I have NEVER been this sick or experienced debilitating pain before. I finally took Tylenol pm to sleep, it didn't help.  I'm a massage therapist, in my 18yr of full time practice. I was noticeably weaker when I returning to work, this lasted 6+months.
Patient was transferred to Hospital from different Hospital with acute hypoxic respiratory failure, COVID pneumonia, afib with RVR, and pulmonary vascular congestion.  CTA chest was negative for a PE but again demonstrated concern for an atypical pneumonia along with evidence of pulmonary vascular congestion.  She was noted to be in afib with RVR and was placed on a cardizem gtt.  She received a dose of lovenox as her INR was subtherapeutic at 1.3.  Kidney function appeared stable.  Received a dose of dexamethasone at the other hospital.  BP is on low side while on the cardizem but HR is now in the 80s.  She is on 3-4L O2 NC.  She was placed on dexamethasone and remdesivir, but remdesivir was stopped due to elevated liver function tests
she had covid four times; she had covid four times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she had covid four times". Clinical Course: Caller was called to got some covid test. She said that they sent her three to four boxes last year. She wanted to know if they still supply a home testing kit. Caller mentioned that she had covid four times (not clarified if covid virus or shots).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10-17-12 Developed erythema that extended down his (L) arm to his elbow, with warmth to touch. No fever. 10-18-12 AM wife reported sx to us - he also c/o's H/A and some discomfort at site. On 10-22-12 wife notified me that by 10-20-12 his symptoms resolved.
itches a little bit now and then; redness/It's a little red on her chest and back of her neck; large hot red spot on my arm/about the size of a baseball/increased in size down her arm; it's like a slight sunburn; This spontaneous case was reported by a consumer and describes the occurrence of SUNBURN (it's like a slight sunburn), PRURITUS (itches a little bit now and then), ERYTHEMA (redness/It's a little red on her chest and back of her neck) and VACCINATION SITE ERYTHEMA (large hot red spot on my arm/about the size of a baseball/increased in size down her arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SUNBURN (it's like a slight sunburn). On an unknown date, the patient experienced PRURITUS (itches a little bit now and then), ERYTHEMA (redness/It's a little red on her chest and back of her neck) and VACCINATION SITE ERYTHEMA (large hot red spot on my arm/about the size of a baseball/increased in size down her arm). At the time of the report, SUNBURN (it's like a slight sunburn), PRURITUS (itches a little bit now and then), ERYTHEMA (redness/It's a little red on her chest and back of her neck) and VACCINATION SITE ERYTHEMA (large hot red spot on my arm/about the size of a baseball/increased in size down her arm) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided. The action taken for mRNA-1273 was not applicable.
Starting the following evening after the vaccine at approximately 9:00pm on Wednesday, my stomach started hurting - from then all the way through the following morning around 4:00am I experienced diarrhea, vomiting (7-8 times), fever and severe chills. As of this morning (Thursday), I no longer have a fever, chills, diarrhea or vomiting, but have intermittent stomach/intestinal pain and exhaustion/fatigue.
Inside of body felt like it was on FIRE!! Mouth burning! Heart racing with minimal movement, shortness of breath,
15 minutes post vaccine felt like her heart was racing/working harder then developed chills.  BP 144/88 P-67 PO 100% R/A
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-year-old patient of unknown gender. On 21-JUN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N021720, expiration date 10-AUG-2019 (exact dose and route of administration were not reported) for prophylaxis. This is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1807USA011661:
brain fog  (spaced out) causing slurred speech, word forming, inability to concentrate 24/7.  Had an MRI, CT and EEG (all results were normal) and several blood test, (low b12 was corrected, working on the low tsh level.  This started 4/6/21 while I was at Cardio therapy that I had been doing for 2 months, blood pressure and pulse were both fine at the onset of the brain fog.
headache; chills; body aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (chills) and PAIN (body aches) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (headache), CHILLS (chills) and PAIN (body aches). At the time of the report, HEADACHE (headache), CHILLS (chills) and PAIN (body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
4 ,months after receiving  her 3rd Moderna MRNA vaccine, patient was found to have extensive metastatic disease to her liver, bones and lungs.
8 days after my 1st vaccination, I woke up to the injection site being swollen, hot, red & extremely itchy.  The swelling is about 2-3 inches in diameter.
The patient called today and said she got the vaccine on Friday. On Saturday she woke up with a rash/hives on her opposite arm. Today, she woke up with the same hives on her face. I asked if she had any difficulty breathing or blisters anywhere including her mouth and she said no. I advised if those symptoms show up to go to nearest ER, otherwise contact her primary care doctor in the morning. I advised she could take some benedryl.  She said she doesn't have a primary care doctor but sees people at the clinic at hospital.
Information received on 27JAN2015 from an assistant study coordinator of military facility. On an unspecified date in June 2014, a 27 year old female (gravida 2 para 1) received a primary dose of BIOTHRAX (lot unknown) at 1+3 estimated gestational age (EGA). In August 2014 the subject was determined to be pregnant (32 days after vaccination). In January 2015 she contacted the investigator for possible enrollment in an ongoing pregnancy registry. At that time she indicated that she had miscarried in September 2014 at 13+2 EGA. The outcome was unknown at the time of the report. No other information was provided regarding other vaccinations, treatments, concurrent medical conditions or medications, medical history, or relevant laboratory/diagnostic results. Additional information has been requested.
Became dizzy, nauseated, diaphoretic. HR 40 .  Taken to ER - care turned over to ER nurse.
1st dose Sept2021 and 2nd dose Jan2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on September 2021).   In January 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. In January 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacists reported that the patient was late for his 2nd dose of Twinrix, which led to lengthening of vaccination schedule.  The reporter consented to follow up. No additional information available from pharmacist since she didn't have their profiles available. This case has been linked with the case US2022047722 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022047722:Same reporter.
GARDASIL 9 given in error 5/20/16. Patient had been given GARDASIL 4 on 5/12/15, 6/16/15, and 11/17/15. Pt has received #4 GARDASILS - extra dose.
06/14/08 started to break out in hairline. Spots red, raised all over trunk/extremities. T 104.4 06/14/08 pm. MOTRIN given at 1am and 7A on 6/15/08. Fever broke. BENADRYL q 5h. Saw ARNP on 6/16/08 8a-dx reaction to varicella shot.
Information has been received from a registered nurse concerning a patient who on an unspecified date, was vaccinated with a dose of VAQTA (lot# not reported). The nurse stated that the patient received the second dose of VAQTA (lot# not reported) 4 months after the first dose. No adverse effect was reported. Additional information has been requested.
L upper arm markedly swollen hot, red, tender; no fever. On 6/25/01 came to clinic for TB reading.
on admission to hosp, pt stated she's had 6-8 wks of coughing, increasing dyspnea with exertion; O2 sat 85% at home on RA; was seen 3 days prior to this admission in outside ER with diagnosis of bilateral PNA; started on antibiotics; back to this ED with increasing SOB; O2 requirements escalated, 15 L HFNC and NRB to maintain O2 sats greater than 90%; treated with dexamethasone, remdesivir, baricitinib, therapeutic lovenox; suffered cardiogenic shock; transferred to ICU for hemodynamic monitoring; suffered hypotension while being prepped for arterial line; became unresponsive and pulseless; CPR; intubation; ROSC was achieved; pt requested limited CPR; pt again became pulseless and CPR was not started due to pt's request; pt died in the hospital
The arm at site of injection, swelled up severely and was burning, red-hot. The ER administered Benadryl and topically with triamcinolone cream.
Nausea, chills, diarrhea.  Pain, redness, swelling and itching of injection site.  Enlarged lymph nodes under arm.
Patient has total hip replacement surgery on 3/4/2020 at the Hospital. After taking the two vaccines on the same day (on the same arm), about 10 hours later, fever (up to 102 degree) developed and the upper inner thigh joint area of the operative leg hurt very badly (score 10 with scale of 1 to 10). The adverse event went away after 36 hours or so.
Information has been received on 14-NOV-2018 from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 24-SEP-2012, a physician administered the ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about November 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756547A, A0756549A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The reporter indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
pt recv vax 15OCT96 devel swelling in arm from the deltoid to elbow & exp soreness @ inj site;
disoriented a little bit; might be having an allergic reaction; fever; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (disoriented a little bit), HYPERSENSITIVITY (might be having an allergic reaction) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced DISORIENTATION (disoriented a little bit), HYPERSENSITIVITY (might be having an allergic reaction) and PYREXIA (fever). At the time of the report, DISORIENTATION (disoriented a little bit), HYPERSENSITIVITY (might be having an allergic reaction) and PYREXIA (fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient discussed their case with their primary care physician. No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up information received on 22-Jul-2021 and included New reporter details were added.
Donor was immunized on 06/01/18, experienced symptoms on 06/02/18, and reported the symptoms to the donor center on 06/18/18. Donor stated that when she woke up on 06/02/18 with a fever of 100.2 and experienced flu-like symptoms. Donor stated that the symptoms subsided on the evening of 06/02/18.
Pt returned to the Pharmacy on 8-24-12 with a swollen bruised area at the site of vaccine injection. Length 3.5 inches and width of approximately 1.2 to 1.6 inches.
had the shot in 2020 and had Shingles / suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had the shot in 2020 and had Shingles for the first time summer of 2021. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Patient, then his wife vaccinated. They were instructed to wait 15 minutes before leaving. Both were fine when I left the car. A few minutes later his wife came to state he was having a reaction to the vaccine. I went to the car immediately whilst another nurse went to get the emergency kit. Patient was very diaphoretic, nauseated, pale and shivering, with weak thready pulse. Family helped put the back of the seat all the way back. Initial pulse ox 94%, HR at that time 58/minute. BP  was checked a couple minutes later 122/76. Within 5 minutes, he was beginning to feel cold, so covered him with his jacket. EMS was called for back-up. Upon their arrival, he was doing much better. Skin was cool and dry. Nausea had subsided and vital signs when checked by EMS were normal: Pulse Ox 98%, HR 68/minute, BP 118/86.  Patient had not eaten breakfast, which he normally does and was now hungry. Family opted not to go to the ER, but to follow up with their family doctor at home. Questions answered by paramedics and myself.
I received vaccine on Monday 1/4, on Wednesday 1/6 started developing some symptoms (tongue felt funny and slight loss of taste), by Thursday morning 1/7 my lip was funny feeling as well and by Thursday evening right side of my face was droopy.  Saw my PCP on Friday and was diagnosed with Bells Palsy.
Patient experienced hives all over her body, even soles of her feet; tongue swelled, even hives on tongue became worse, went to hospital ER at 6:30 AM 10/30/04 and was treated.
Rash/redness on arm; Rash/redness on arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 82 year-old male patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), ERYTHEMA (non-serious) all with onset Oct2021, outcome "not recovered" and all described as "Rash/redness on arm". It was unknown if therapeutic measures were taken as a result of rash, erythema.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Other vaccine in four weeks was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever 102, severe migraine, dizziness, stiff neck, enlarged axillary lymph nodes, chills, body aches.
Immediate headache (within 5 minutes). Throughout the day and the following day (4/10) until about 5:15 - fever, headache, nausea, sore throat, fatigue, body pains, dizziness, mental fogginess, slight chest congestion and runny nose. It was like it was going in cycles non-stop then suddenly it stopped around 5:15 pm the next day and I felt okay.
Nausea, vomiting, body aches, chest pain, large red area at injection site with swelling, fever of 103, went to urgent care 15 November TYLENOL w/codeine given antibiotics. Also prescribed steroid on 18Nov14. Redness and swelling only at site of pneumonia vaccine.