chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per Patient He had :   " irritability/pain in my connective tissues, including finger joints, teeth ligaments, and knees, from relatively mild stress (squeezing wet clothes, chewing, walking). Post-stress the tissues remained sensitive for hours - even pushing with my tongue on a tooth that had a root canal would cause a slight pain, and I felt pain and stiffness when making a fist after squeezing the clothes."  Symptoms mostly resolved the next day.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On 22-AUG-2012 the patient was inoculated with ZOSTAVAX by a pharmacist to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot #, expiry date not provided). On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, (vaccination failure) and suffered serious physical, emotional, and economic damages as a result of patient's injuries. The patient was treated by a healthcare provider for shingles on an unknown date in 2016. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue 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. The outcome of the events was not reported. The events were considered to be related to ZOSTAVAX.
Pt was waiting in observation area after receiving her covid vaccine. PT began feeling dizzy and lightheaded. Pt fainted briefly and EMS responded immediately. Fire/Rescue immediately responded shortly after. Pt regained consciousness and was evaluated by EMS and Fire/Rescue. Pt stated she has this kind of medical episode every so often. Last episode was 3 months ago. Pt and EMS do not believe this was directly related to the Covid vaccine. Pts vital were stable and exited premises on her own. Pt had family waiting for her in the the parking lot.
Information has been received from a nurse and medical records through the pregnancy registry for Gardasil concerning a 15 year old female with an environmental allergy and migraines, a history of UTI, and an otherwise unremarkable medical history, who on 30-MAR-2007 was vaccinated intramuscularly in the left arm with the first dose of Gardasil (0.5 ml) (lot # 654535/0960F). Concomitant therapy included CLARITIN and PERIACTIN. It was reported that the patient's pediatrician was notified by an OB/GYN's office that the patient was pregnant. The patient's LMP was 17-MAR-2007 (also reported as 24-JUL-2007). This was the patient's first pregnancy. An ultrasound on 07-AUG-2007 showed 33 weeks gestation. The patient did not seek treatment with the OB/GYN until she presented with increasing labor pains and gush of clear fluid. The loss of fluid occurred at 08:45 and shortly her contractions markedly increased in strength. When she presented, she was 4 to 5 cm and was managed expectantly. She was noted to be completely dilated at 1413 hours and the baby delivered in the right occiput anterior position at 1520. Nasal and oropharynx were suctioned in the perineum and gentle posterior traction was applied to the head to deliver the anterior shoulder. Once both shoulders were out, the patient reached down and delivered the remainder of the baby on her own. It was reported that the baby had a short cord and when elevated above the perineum approximately 8 inches, the cord broke after having very little traction applied to it. The point where the break occurred was approximately 1 inch away from the umbilicus of the baby which was grabbed  by the physician and pressure was applied. A Kelly clamp was applied to the area and therein stopped further bleeding. Overall blood loss was approximately 50 cc. The placenta was expressed and noted to have a three-vessel cord and was intact. Inspection of the perineum noted second-degree perineal lacerations which were repaired in a standard fashion with 3.0 Vicryl suture. The patient delivered a full term normal baby girl weighing 7 pounds 8.4 ounces with a length of 19.9 inches, apgar 8/9 with no apparent problems. There were no congenital anomalies and no other complications or abnormalities. On 17-SEP-2007, the baby was examined and was noted to have marked moldings with a temperature of 99 degrees rectally. The patient (mother) was also reported to have had condylomula and a positive HPV test. The patient was discharged after delivery on 19-SEP-2007. No further information is expected. Pediatric medical records were received and reviewed; adverse experiences related to hepatitis B virus vaccine were identified, and are described in WAES # 0803USA04159.
NO adverse effect; both vaccines PROQUAD & VARIVAX were inadvertently administered to a patient at the same time on 07/27/2023.; This spontaneous report was received from a health care professional (HCP) referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions, and allergies were not reported.  On 27-JUL-223, the patient was inadvertently vaccinated at the same time with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection (strength and route of administration not reported, lot # X000996, expiry date: 08-JUL-2024), and 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength and route of administration not reported, lot # X002100, expiry date: 19-JAN-2025) for prophylaxis (accidental overdose). The patient did not experience any symptoms. No additional adverse event (AE) (no adverse event).
Approximately 12 hours post-vaccination, I awoke with an extremely high fever, uncontrollable shivering, and profuse body aches, accompanied by redness, swelling, and pain in my upper arm where the vaccination was administered.  My fever, uncontrollable shivering, and profuse body aches persisted for 14 hours until my fever broke at approximately 5 pm the day following my vaccination.  The redness, swelling, and pain in my upper arm  continues to persist; although, it has improved.
Pain between shoulder & elbow. Decreased mobility of left arm. Patient took naproxen & TYLENOL per MD instructions.
Patient had stated that they had an anaphylactic reaction with aspirin & ibuprofen.  Prior to vaccination they were asked to stay in the area for 30 minutes for observation.  About 25 minutes following vaccine patient was feeling a heavy chest and tongue was feeling funny.  Pharmacist administered 50mg of liquid Diphenhydramine to the patient 30 minutes following vaccination and she waited in the pharmacy area until symptoms cleared.  Only symptoms when she left was a little bit of drowsiness.
Temperature; chills; body aches; headaches; nausea; vomiting; diarrhea; fatigue; stomach pains; This is a spontaneous report from a contactable other healthcare professional (patient). This 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3249) via an unspecified route of administration in the left arm on 11Jan2021 at 10:45 at single dose for COVID-19 immunisation. Relevant medical history included penicillin allergy and allergy to clindamycin and doxycycline. Concomitant medications were not reported. The patient had a nasal swab COVID test result positive on 01Jan2021 after the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EJ1685) administered on 21Dec2020 in the left arm for COVID-19 immunization. On 11Jan2021 at 21:00, the patient experienced temperature, chills, body aches, headaches, nausea, vomiting, diarrhea, fatigue and stomach pains. The patient underwent a Nasal Swab on 11Jan2021 which was positive. The patient did not receive corrective treatments. The patient had not recovered from the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021030273 same reporter/patient, different dose of COVID-19 vaccine/event
This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. This spontaneous report was received from a consumer and concerns a subject of unspecified age and gender. The subject's height and weight was not reported. The subject's concurrent conditions included chronic hepatitis C. The subject received typhoid vaccine oral ty21a (capsule, hard, oral) on an unspecified date as a prophylactic vaccination. Concomitant medications were not reported. On an unspecified date, the subject experienced increased RNA count. The reporter stated that last April (year unspecified) RNA count was 374, 000 and within 3 weeks of taking oral typhoid vaccine oral ty21a the subject's RNA count went up to 3,100,000. Action taken with typhoid vaccine oral ty21a was unknown. The subject outcome was unknown for increased RNA count. This report was serious (medically significant).
Pain and hardness at injection site, radiates down arm and into joints, shoulder, elbow, bicep, forearm all the way to fingers.   Still happening a month later.
Myalgia, Arthralgia & Fever Narrative:  After 2nd covid vaccination employee experienced fever, chills, nausea, muscle aches, joint aches that last for 48-72 hours. Headache 1/22-present.
It started the morning after receiving the booster, I had soreness in my arm and under my armpit. I had discomfort from the prior 2 doses so I didn't think anything of it. I went to my desk to begin work and had this weird burning sensation in my lungs; I wasn't gasping for breath, and my heart rate was normal. I took a TUMS to try to reduce the pain and laid down. Nothing was helping, so I called my family doctor to tell her my symptoms. She told me to go to the ER to get scanned for a pulmonary embolism. I went, they put me on an IV and performed an EKG as well as took some blood for testing . They didn't detect anything abnormal in the scan; they believed I had come in contact with the Omicron COVID-19 variant prior to receiving the booster, and the booster shot caused a reaction and internal inflammation as response to contact to the virus. They prescribed me Prednisone  oral steroid to help reduce the inflammation as well as Mucinex; the lung capacity has been steadily improving, however I'm still having a somewhat persistent cough. It's getting better, but hasn't fully gone away.
Constant ache in shoulder, unable to lift arm across body or lift arm overhead. Talked with pharmacist, saw doctor at minor emergency clinic, treated at orthopedic clinic, physical therapy...continue to have pain and ache in upper arm significantly at night, prescribed Mobic... one month course no effect, now going on two months difficulty dressing when having to use arm crossing body and pulling over had.
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a non-health care professional (Office Staff manager).This case is linked to cases 2018SA289714, 2018SA289702, 2018SA289666, 2018SA289651, 2018SA289640, 2018SA289611, 2018SA289688, 2018SA289731 and 2018SA290377, same reporter. This case involves a 13 years old male patient who received vaccine IPOL. The patients past medical history, concomitant medication and family history were not provided. On 18-Sep-2018, the patient received injection of suspect IPOL lot number- N1K931M, expiry date and dose not reported via unknown route in unknown administration site. It was an actual medication error due to incorrect product storage. It was reported that IPOL opened reached 32.76 F for 19 hours 44 minutes/ did not freeze, doses were indeed given out of opened multi dose vial of IPOL after temperature excursion. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Dtap #3 (Sanofi - Lot #U2354CA) given on 12/12/07.  Entire left thigh erythema, not painful, indurated with some increased adenopathy, fever 101 on 12/13/07.
Patient stated they after receiving vaccine she started feeling lethargic, nauseous, having body aches, and her arm was very sore. She called her doctor and they told her to call pharmacy. As of time of filing this report patient is still experiencing adverse effects.
Patient got the vaccine on 12/31/2020. Had very sore shoulders could hardly get up. Talked to her on the 9th and she said she could not see out of her eyes correctly. Could not text me anymore. She texted every day. My sister called on the 16 said mom was not taking correctly . She was having a stroke. Had to take her in 4 times before they would admit her. Did not give her an MRI until the next afternoon.
Nausea started around 8:00 p.m., first vomit was at around 8:30, then vomiting occurred every hour for 5 plus hours, headache, and  diarahea,  Lasted  until around 1:00 a.m. with nausea throughout the next day, slept from 5:00 p.m. through the morning, waking at 6:30 a.m. feeling somewhat better. No nausea or headaches.
2 days after my shot I started developing small bumps on my hands. They progressed throughout the next few days into large clusters of bumps that covered the entire back side of my hands and slightly on my arms and feet. I also developed red circles on the palms of my hands and feet. I took otc antihistamines including Benadryl and Zyrtec for 4 days which was ineffective. To this day, 16 days after the vaccine, I still have the bumps on covering the backs of my hands, and now covering 70% of the tops of my feet, with the red dots still showing on the palms of my hands and bottom of my feet.
Pt to ED 6/6 c/o coughing beginning yesterday, extremely short of breath. Pt SP02 in the 70's and low 80's on a non rebreather. COVID+ 6/6. 6/7 pt aintained on BiPAP, tolerated well, patient had decreased O2 requirement. 6/8 pt maintained on Rocephin and Zithromax and I started vancomycin. 6/9 pt aox4 with delayed responses, pleasant & cooperative no signs of distress. 6/10 Patient aox4 pleasant & cooperative, on 15L cold flow, pt denied any pain, no signs of distress. 6/11 pt A&Ox4 with delayed response, on 10 L high flow, no SOB. 6/13 pt A&Ox4, on 2L NC. Pt discharged 6/13, on room air at discharge.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with improperly stored doses of VARIVAX (L021210 with expiration date 10-JUN-2017, lot# was reported as L045955 with expiration date 17-NOV-2017, dose and route unknown). The vaccines were stored under 6.6 F for 20 minutes without previous excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Tingling in mouth and chin; Headache; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tingling in mouth and chin), PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 11-Feb-2021, the patient experienced PARAESTHESIA ORAL (Tingling in mouth and chin) and HEADACHE (Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at a dose of unknown. At the time of the report, PARAESTHESIA ORAL (Tingling in mouth and chin), PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
(Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Muscle cramps and shaking worse; Muscle cramps and shaking worse; Condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle cramps and shaking worse), TREMOR (Muscle cramps and shaking worse) and CONDITION AGGRAVATED (Condition aggravated) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Muscle cramps and shaking worse), TREMOR (Muscle cramps and shaking worse) and CONDITION AGGRAVATED (Condition aggravated). At the time of the report, MUSCLE SPASMS (Muscle cramps and shaking worse), TREMOR (Muscle cramps and shaking worse) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Pt experienced an injection site reaction characterized by redness, heat and swelling to the size of a baseball. Pt advised to treat with heat/cold alternately and Motrin or Tylenol.
Symptoms noticed while working out at a fitness gym.  Noticed left arm had been severely weakened compared to right arm during lifting session.  Lost over half its strength comparitvely. Mild soreness in area of vaccine.  Condition has not improved at all since vaccine.
Myalgias, fever x 3 days. Bilateral vesicular erythematous chest rash x 7 days.
2 vaccines given 7/15/13. 2nd dose first 4/30/13 Rt arm - VARIVAX - local reaction erythema 6 x 10 cm. 3 days after vaccine lips swelling - resolved. Urticaria - extremities onset 7/18/13.
This spontaneous report as received from a pharmacist via a company representative refers to an unspecified number of adult patients of unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. The pharmacist reported that on unknown dates, each adult patient who came to the pharmacy for the PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported) and one dose of PREVNAR 13 (dose, route of administration, lot # and expiration date were not reported) separated by one year. It was unspecified in what order these vaccines were administered. No adverse events symptoms were reported. Additional information has been requested.
Breakthrough COVID-19 infection. Tested positive on 09/02/2021. Patient fully vaccinated on 02/06/2021.
This spontaneous report as received from a pharmacist refers to a 50 year old female patient. On 10-APR-2013 the patient received the first dose of RECOMBIVAX HB, second dose on 14-MAY-2013 and the third dose on 20-AUG-2013 (lot # not reported), "10 mcg/3 doses", intramuscular. No adverse effect. Additional information has been requested.
Headache, fever, body aches, fatigue and injection site bump along with red circular rash.  Injection bump remains 9 days post vaccination.
I experienced a slight fever, severe headache, nausea, and vomiting which caused an emergency room visit for safety considerations and received two liters of fluid.
Information has been received from a nurse practitioner and a registered nurse that a female who in 2007 was vaccinated with the first dose of GARDASIL (lot number not provided), in 2008 was vaccinated with the second dose of GARDASIL (lot number not provided), in 2009 was vaccinated with the third dose of GARDASIL (lot number not provided). It was reported that the patient had received the GARDASIL vaccinations at another physician's office. On 16-AUG-2010 the patient experienced the first grand mal seizure. The registered nurse stated that the patient has had a "bad year". The patient was a junior in high school and was "pretty much homebound at this time", per the patient's mother. The patient has seen a neurologist and a cardiologist (name of physicians were unknown to the reporter). At time of the report, the patient's outcome was unknown. Grand mal seizure was considered to be disabling by the reporter. Additional information has been requested.
Had the chills and dry heaving and dizzy. She had a temp of 100.5
pt recvd vax 28NOV94; ran fever of 105.2; had to take pt to ER; pt was there for 5 hrs; pt was given suppository for fever; note from pediatrician recommending no more pertussis;
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 80-year-old male patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020. Concomitant products included Pravastatin, Vitamin D3, metoprolol and Triptorelin. On 10th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5ml. On 11th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, fatigue, muscle pain, injection site erythema, injection site swelling, facial pain, neck pain and shoulder pain. In April 2018, the patient experienced facial swelling. On an unknown date, the outcome of the injection site pain, fatigue, muscle pain, injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the facial swelling, facial pain, neck pain and shoulder pain were unknown. It was unknown if the reporter considered the injection site pain, fatigue, muscle pain, injection site erythema, injection site swelling, facial swelling, facial pain, neck pain and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a registered nurse. The patient received SHINGRIX vaccine on an unknown deltoid. The nurse reported that the patient experienced pain, redness, swelling, and burning at his injection site, and experienced swelling on his face, muscle aches, and fatigue. Also, the nurse reported that the patient experienced the pain at his injection site radiating to his shoulder, neck, and face. The nurse also reported that she had other patients of unknown number that reported discomfort after the injection. This case was linked with US2018GSK071969, reported by the same reporter.
exp sz; ER; tests done; tx: phenobarbital-sent home;2 days later, another sz; to ER; transport to specialty hosp w/ O2;4 sz in all;now on phenobarbital every 12hr to control sz; per mom, neurologists say only logical explanation is vax