chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via market research programs and described the occurrence of immune-mediated adverse reaction in a adult patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis. On an unknown date, the patient received Hz/su + AS01B at an unknown dose. On an unknown date, unknown after receiving Hz/su + AS01B, the patient experienced immune-mediated adverse reaction (serious criteria death and GSK medically significant). On an unknown date, the outcome of the immune-mediated adverse reaction was fatal. The reported cause of death was immune-mediated adverse reaction. The reporter considered the immune-mediated adverse reaction to be possibly related to Hz/su + AS01B. Additional details were provided as follows: This case was reported via interactive digital media. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The physician posted, a closed doctors forum that it was funny to see this post here after I had 2 cases of death following SHINGRIX vaccination. Both were devastating. It was lucky that your patient only got the rash. The physician was reported to Centers for Disease Control and Prevention (CDC). Cause of death did not seem infection related but more so of a exacerbated immunologic response to the vaccination. The physician written them up as case report. The physician would advise against giving this vaccination to any the patients who were receiving immunotherapy for either oncologic or rheumatologic conditions. The famous last words the heard from their documents were but they were not live virus. This case was 1 of the 10 cases, reported by same reporter. Reported Cause(s) of Death: Immune-mediated adverse reaction.
Pt developed fatigue evening of vaccine admin. Pt woke up following AM around 5/5:30AM for work and with "horrible HA", chills, body aches. Denies associated cough/congestion, rhinorrhea. HA is unamendable to Tylenol. He is fatigued and has slept most of the day. Advised to treat with ibuprofen, hydration, rest.
Patient with a history of vasovagal reactions first experienced shakiness and  diaphoresis and thenhad a brief (<30 seconds) loss  of consciousness but without loss of postural tone about 2-3 minutes after the injection.  BP-148/82 P-86 O2- 99% Monitored, offered fluids, recovered fully and was discharged home.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 64-year-old female patient. No information was provided regarding medical history, concurrent conditions or concomitant medications. On an unknown date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) by a pharmacist at a pharmacy (lot#, expiration date, dose and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced Herpes Zoster. On an unspecified date, the patient was treated by a physician for Herpes Zoster. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Patient's reaction(s) noted during COVID vaccine observation period: Shortness of breath, throat tightness Actions Taken: Pt felt better within a few seconds. She thinks it was anxiety/panic attack after receiving her vaccine as the tightness/SOB only lasted a few seconds.    She was walked by an RN from the vaccine administration area to observation area and took a set VS. VS were normal with a slightly elevated SBP.   Pt stayed in observation area for a little longer to make sure she felt okay. Pt went home, declined ED visit
Projectile vomiting twice, once at 07:17 PM and again at 09:30 PM.
Female patient 91 year old oriented X3 in wheelchair accompanied by her son, she reports 8 days after receiving her first dose vaccine PFIZER with pain, inflammation and "numbness" in the joints. Patient reports pain in the neck, arms, wrists, knees and in the left lower limb, it radiates to the ankle.
arm was sore; swollen lymph node on the right side of neck; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm was sore) and LYMPHADENOPATHY (swollen lymph node on the right side of neck) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 23-Sep-2023, the patient experienced PAIN IN EXTREMITY (arm was sore) and LYMPHADENOPATHY (swollen lymph node on the right side of neck). At the time of the report, PAIN IN EXTREMITY (arm was sore) and LYMPHADENOPATHY (swollen lymph node on the right side of neck) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.
Light-headed dizziness, once sittg up fell backwards had no control over my body, also when I put my head on the pillow to go to sleep it happened. Happened when I moved my head from side to side. Well walking I had to hold on to something until it passed. Some headache. I do have headaches anyway so I'm not sure if that was the cause. My concern is the dizziness and the lightheadedness and loss of control, not immediately following the vaccine but three days later. Not sure if the delay in side effects is normal.
Fever of 103; This case was reported by a other health professional via sales rep and described the occurrence of fever in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had fever of 103 degree F. The reporter asked for medical informations phone to call them.      Lab Comments: Lab test performed on unknown date
Left arm swelling, redness, warmth, and tenderness to the injection site. Generalized bodyaches, headache, nausea, & fatigue.
This spontaneous report was received from a consumer via Pfizer and refers to a male patient of unknown age. There was no information about patient's concomitant medications, pertinent medical history, drug reactions or allergies provided. In 2015, reported as "a couple of weeks ago", the patient was vaccinated with PNEUMOVAX 23 (lot#, expiration date, dose, site and route of administration were not reported). Subsequently in 2015, the patient experienced reaction to PNEUMOVAX 23. The outcome of the event was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. Additional information is not expected, as no contact details were provided.
Friday evening - arm soreness, headache, Saturday morning - achy, chest pain, shoulder pain, shortness of breath, fatigue - all resolved
So far I've had a shingles outbreak; ringing in my ear after COVID boosters; This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (So far I've had a shingles outbreak) and TINNITUS (ringing in my ear after COVID boosters) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (So far I've had a shingles outbreak) and TINNITUS (ringing in my ear after COVID boosters). At the time of the report, HERPES ZOSTER (So far I've had a shingles outbreak) and TINNITUS (ringing in my ear after COVID boosters) outcome was unknown.            No concomitant medication information provided.  It was reported that patient had taken the Moderna COVID shots and had a shingles outbreak and ringing in ear after COVID boosters. Not planning to take anymore.  No treatment information provided.
acute ischemic stroke. pt was admitted to the ICU and is currently being treated. pt was taken emergently to IR for mechanical thrombectomy. also received alteplase.
This spontaneous report was received from a medical assistant and refers to a patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX 0.5 ml, subcutaneously, lot # M023379 with an expiration date: 11-MAY-2018. Administered dose of VARIVAX experienced temperature excursion of 11.1 Celsius degree for 1 hour 40 minutes, on an unknown date. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
sore left arm for approx. 1 week,  rash at injection site for 1-2 weeks, low grade fever w/ chills for 12 hrs., headache at back of lower head/neck area 12-24 hrs, painful glands left side of body for 2-3 days, tight chest w/ cough for 3 days
No adverse effects from the first injection (4/6/2021). However, after the second injection (5/4/2021), I got chills and headaches etc to which I took a day off from work on the following day and rested in bed while taking Tylenol which seemed to help ease off the effects.  A few days later, I think on the weekend I started developing burning feeling in my lower legs, front shin and side areas in both legs, almost like shin splints and general light headedness. I had not exercised nor done anything different that may have contributed to this burning feeling in my legs. I had to travel abroad afterwards and I could not really tend to it. Now almost two months later the burning feeling has not subsided and it comes and goes depending in different intensities.
Patient was given booster and not Initial series of Moderna.  This was her first shot of the Moderna series.
pt was in the hospital, local Medical Center, from 12/30/2021 - 01/1/2022 with acute on chronic respiratory failure; positive for COVID, NSTEMI; pt had been weak, with fever and chills prior to admission;  placed on steroids, O2 supplementation; pt continued to improve and she went home where she passed away.
Patient went to Doctor for routine Physical Examination.  Approx. 5 minutes after given Gardasil Shot, patient lost consciousness.  During the loss of consciousness, her arms and legs seized up and her hands seized up at the wrists.  She was making a gurgling noise with her mouth and her head/neck were seizing, bringing her chin down to her chest.  After about 60 seconds, the nurses and doctor were able to revive her by leaning her forward and calling her name twice.  Patient is a very healthy female with no existing medical conditions and no family history of seizures or fainting spells.
On 7/11/2021 patient said she experienced a heart attack and had to be admitted into the hospital. They did tests and her troponin levels were elevated. No further information was given on how long she was in hospital. No past history of a heart attack either.
Pt recv vax on 6/22/88; on same day pt exp irritability, seizures; pt hosp; pt exp mental retardation
Leg pain which increased in intensity over the next two weeks. Muscle spasms in legs, cramping in calves, nerve pain in lower legs. Treated with prednisone and pain medication. Day 18, pain started to subside.
Day1 11:39 AM  after my vaccine I feel a burning sensation thru my arm.  5:00 PM I pain started thru out my arm and neck. I drink 2 pills of Tylenol for the pain on my arm every 8 hrs. Day 2  More pain on my left arm and swollen finger and chest (cervical ) and I feel a  bump in my cervical area .
Information has been received from a registered nurse concerning six patients who were vaccinated with varicella virus vaccine live, 0.5 mL, injection (Oka/Merck) (Lot # and route not provided). Subsequently, the patient developed chicken pox and had been previously vaccinated. Unspecified medical attention was sought. The patient outcomes were not reported. There was no product quality complaint. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Further information has been received from a school nurse who reported a female was vaccinated with varicella virus vaccine live on 24-JUL-1995. The nurse reported that the patient developed chickenpox. All of the parents and pediatrician felt the cases were mild with minimal missed time at school (approx 2-3 days out sick). This is one of several reports from the same source.
PCV 13 vaccines was given on 4/28/11 and pt came 4/29/11 w/c/o redness & swelling on left deltoid area. Pt had no fever. KELFEX was given to pt 250mg/5ml 8 ml PO BID x 10 days. Diagnosed w/cellulitis. Pt seen for a follow up 5/6/11. Cellulitis resolved.
COVID vaccine breakthrough case. Moderna 2/15/21 031L20A, 3/15/21 030A21A,  boosted 11/4/21 076C21A,  6/8/22 058A22-2A
Extreme weakness, especially of legs; ache in lower abdomen; vomiting and inability to hold even water down; diminution of vision; fever of 100.3; I slept almost full time from 9:00am until 6:30am the following day, with very brief waking periods.; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional. An 80-years-old female patient (non-pregnant) received the second dose bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection) via an unspecified route of administration, administered in Arm Left on 18Feb2021 16:30 (Lot Number: EN6201, Expiry date was not reported) (at the age of 80-years-old) as a single dose for COVID-19 immunization at the hospital. Medical history included mild allergy to dairy and some fruits. Other medical history was reported as none. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 1 via an unspecified route of administration, administered in Arm Left on 20Jan2021 16:30 Lot Number: F(E?) L3248, Expiry date was not reported) for COVID-19 immunization. The patient did not receive any other vaccine in 4 weeks of COVID vaccine. The patient did not have other medications in two weeks. The patient did not have COVID prior vaccination and COVID was not tested post vaccination. On 20Feb2021, 07:00 the patient experienced extreme weakness, especially of legs, ache in lower abdomen, vomiting and inability to hold even water down, diminution of vision, fever of 100.3, the patient slept almost full time from 9:00am until 6:30am the following day, with very brief waking periods. Laboratory tests on an unspecified date included body temperature: 100.3 (fever 100.3). There was no treatment received for the events. The clinical outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Headache,dizziness, shoulder ache. Transported to medical screening via wheelchair for evaluation by paramedics. Per medic, vitals within normal range. Left in stable condition at 12:35 p.m. Recorded by RN. Paramedic.
I had very mild discomfort the first day or two, but since then my arm hurts so bad that it affects my mobility. It has been 15 days now since I got the shot and I have a very difficult (and painful) time getting a shirt on and off, and it's difficult for me to carry my grandson. I also seem to have extreme fatigue at times.
After the second dose, I got a surprise menstrual period - lasting one day - after having zero periods in two years.  The same thing happened again after my Booster - and that's when I saw my Ob/Gyn.
painful and swollen Nasal congestion; Nasal congestion; Cervical lymphadenopathy; This spontaneous case was reported by an other health care professional and describes the occurrence of RHINALGIA (painful and swollen Nasal congestion), NASAL CONGESTION (Nasal congestion) and LYMPHADENOPATHY (Cervical lymphadenopathy) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Obesity and Allergy.   On 10-Dec-2021 at 1:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 26-May-2022, the patient experienced RHINALGIA (painful and swollen Nasal congestion), NASAL CONGESTION (Nasal congestion) and LYMPHADENOPATHY (Cervical lymphadenopathy). At the time of the report, RHINALGIA (painful and swollen Nasal congestion), NASAL CONGESTION (Nasal congestion) and LYMPHADENOPATHY (Cervical lymphadenopathy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medications were not reported.  It was reported that patient was not taking any medications within 2 weeks of starting the COVID-19 treatment. Patient previously received COVID-19 vaccine. The start date of the events was reported as 26-May-2022 06:00.
This spontaneous report was received from a Medical Assistant refers to a currently 10 weeks old female patient who on 10-SEP-2012 was vaccinated orally with a 2 ml expired dose of ROTATEQ, Lot #1527Z, exp date: 29-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported at that time. Additional information is not expected.
VACCINE ADMINISTERED 12 HOUR + AFTER PUNCTURE AT THIS TIME NO ADVERSE EVENT REPORTED
Information has been received from a registered nurse concerning a 65 to 70 year old male who "about 1.5 years ago" on an unspecified date in 2006 was vaccinated with a dose of Zostavax (Oka/Merck).  Five to 7 days after the vaccination the patient developed chicken pox.  Unspecified medical attention was sought.  Subsequently, the patient recovered from the chicken pox.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Information has been received from a registered nurse concerning a 32 year old female with a positive TB skin test, and no drug reactions or allergies, who on 29 OCT 2007 was vaccinated with a second dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (Lot # 652320/0092F). The patient had received a first dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) on 07-AUG-2007, while out of the country. The patient's husband reported to the nurse that the patient is now pregnant. The patient's LMP was 10 OCT 2007. Other vaccine therapy on 29 OCT 2007 included poliovirus vaccine, hepatitis B virus vaccine rHBsAg (manufacturer unknown), and influenza virus vaccine (unspecified). Follow-up information has been received through the Merck pregnancy registry from a registered nurse concerning this 32 year old female with no known drug allergies and a positive tuberculosis skin test who on 29-OCT-2007 was vaccinated with a second dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (Lot # 652320/0092F). The patient received the first dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) on 07-AUG-2007, while out of the country. Other concomitant vaccinations on the same day included hepatitis B virus vaccine rHBsAg (manufacturer unknown), poliovirus vaccine inactivated (unspecified) (manufacturer unknown), influenza virus vaccine (unspecified) (manufacturer unknown) and diphtheria toxoid/tetanus toxoid (manufacturer unknown). The patient also had a tuberculosis skin test performed. It was noted that the patient delivered a female child on 05-JUL-2008. At 3 weeks old (on approximately 26-JUL-2008) the baby was hospitalized with meningitis for 3 weeks. The baby survived. At the time of the report, the baby's status was unknown. The nurse reported that she does not have all the medical details at this time, the family was traveling out of the country. Upon internal review the baby's meningitis was considered an other important medical event. Additional information has been requested.
7x7.5 cm erythematous, hot, tender to palpation raised region surrounding site of injection.  Tenderness and tightness right lateral shoulder, right lateral neck and up into the jaw.  No swelling of lips, tongue, no swelling of face, no SOA.  She has prominent local reaction with radiating pain into the lateral right elbow and into the shoulder.  Shoulder ROM is mildly reduced secondary to guarding pain but no obvious joint involvement o f shoulder elbow or cervical spine.  Pain locally, fatigue, malaise.
Rash occurred on chexst day of vacc. Red burning ears & swollen glands, staryed day 4.
Symptoms experiencing include generalized body aches, headaches, chills.   Seen in outpatient setting by IDMT Sent home for 24hr quarters
30 Minutes after vaccination given Pt c/o cheeks swelling & feeling warm.  No hives or respiratory symptoms noted.  BP 164/106 P 80 R 16  4:45PM No increase swelling.  BP 148/100 P 80  Released w/o assistance.  Recommended to put ice packs on cheeks or call EMS if symptoms worsen.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 13-OCT-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date- 10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medications was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Donor states one hour after receiving immunization body went numb loc time unknown transported to ER. IV therapy given in ER and released.
Well potty trained started having accidents. Ear problems, constant thirst. Waking at night to drink water and incontinence.
T102-T103.4 after injection was given on 05/12/2005. Still had fever on 5/16/05. Bruising at injection site and warm to touch and hurting on 5/13/05. Injection site got to size of tennis ball by 5/16/05.