chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills with body shaking; Chills with body shaking; Body soreness; Nausea; Fatigue; Swollen lymph nodes; Headache; Joint pain; This is a spontaneous report from a non-contactable other health professional reporting for herself. A 27-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL3246), via an unspecified route of administration in left arm, on 20Jan2021 at 12:15, at single dose, for COVID-19 immunisation. The patient's medical history was not reported. Patient did not have COVID-19 prior to vaccination. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS). The patient previously received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL0140) on 30Dec2020 at 11:00 AM in left arm. The patient experienced chills with body shaking, body soreness, nausea, fatigue, swollen lymph nodes, headache and joint pain all on 21Jan2021 at 12:00 with outcome of recovered on unknown date. No therapeutic measures were taken as a result of the events. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab) on 21Jan2021 (pending result).  No follow-up attempts are possible. No further information is expected.
Tested positive for COVID , I have been in isolation due to scheduled surgery. My spouse (only contact ) repeatedly testing negative on both pcr and antigen test
p/vax pt devel fatigue & headache, at 3:30 itching under arms, posterior knees & soles of feet, 7-7:30, hands red & swollen with hives on wrists, 10-10:30 took benadryl
pt recvd vax; devel fever of 101 ax, swollen leg, large red "hives" area over inject site;given motrin & rxn subsided over next 48 hrs;
Pt received 1st dose of Moderna COVID-19 vaccine on 01/04/2021 in L deltoid. Came back to clinic at 0800 on 01/06/2021 c/o excruciating pain in entire L arm radiating to neck, chest, and around his upper and lower back. States it started the evening of 01/04/2021 and progressively has gotten worse. States it woke him up at 0130 on 01/06/2021 and that he hadn't been able to get back to sleep because of the pain. Rated pain 9.5/10. No redness or s/s of infection at injection site. Some swelling present at the site. L forearm and hand were slightly erythematous, and he was unable to move arm or fingers much. RN had to assist with putting his jacket back on. States has tried ice packs, tylenol, ibuprofen, tramadol, gabapentin, and oxycodone with no relief. BP 143/93, P 77, RR 22, O2 sat 96%. Advised to call PCP and either wait until urgent care in town opens at 1100, or if he can safely drive to another city, go to urgent care there because they open at 0800. Advised if unable to drive to other city and can't wait until 1100, to go to the ER.   On 01/07/2021, called pt in the evening to follow up. Pt stated he did go to the ER in town right after coming to the clinic, where they performed an ultrasound of his arm to check for retained fluid, but his results were normal. Pt states ER advised him to try hot packs on his arm and to return if he still found no relief. Pt states the hot packs did help some, but was still experiencing pain 6/10, but that the intensity of it had worn off a little and that it was becoming more manageable
may have received 3 doses of the SHINGRIX vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 1st January 2022) and Shingrix (received 2nd dose 4th March 2022).   On 7th June 2022, the patient received the 3rd dose of Shingrix. On 7th June 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's Comments: The reporter stated that the patient might have received 3 doses of the Shingrix vaccine. It was not confirmed that the patient had received 3 doses. The reporter gave consent for follow-up health care professional provided limited information. Health care professional stated that it was possible that the dates provided refer to billing dates and not administration dates. Health care professional would confirm with the patient Additional Supportive Information:  The patient received 3rd dose of Shingrix after receiving 2 doses which led to, extra dose administered.
On Sunday night I had a sore throat, then on Monday I started having horrible congestion so I tested myself with an at home COVID-19 Test & it was positive. The next day I had a terrible headache and was very fatigued and achy.
3/18/2022 oxygen saturation dropped and supplement oxygen needed. 3/19/2022 patient c/o pain with swollen left side of face and tongue. Transferred to hospital. Hospital gave diagnosis of parotitis. Patient still in hospital at this time.
Patient reported symptoms of nausea and severe lightheadedness approximately 10 minutes after vaccine administration.  Symptoms progressed and patient report feeling  itchy with throat tightness.  New onset of rash on bilateral forearms.  He was elevated by Doctor with recommendation to be transported to the local Emergency Department.   Patient refused to be transported and asked to stay on-site for continued observations.   Patient's symptoms failed to resolve after 45 minutes, rescue team was called.  They presented and evaluated patient with recommendations to be transported to the local Emergency Department.  Patient declined transport to the hospital.  Rescue team spoke with the Emergency Department, the decision was made and the patient agreed to an additional hour of observation with the understanding if symptoms didn't resolve they would be transported to the Emergency Department.   Symptoms unchanged after 1 hour, patient made the decision to leave and follow up with their Primary Care Physician.
Narrative:  Covid dx three weeks ago, pt with CLL ongoing chemo. Pt with generalized weakness and fall. admitted to hospital. Discharged to home with home health services.
Vaccine exposure during pregnancy; Arm tenderness; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and TENDERNESS (Arm tenderness) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Aug-2020 and the estimated date of delivery was 13-May-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and TENDERNESS (Arm tenderness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved and TENDERNESS (Arm tenderness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Extreme stiffness, soreness and pain at the injection site 7 hours after injection. Body aches with chills  14 hours - the next 48 hours. Nausea and tiredness.
Angioedema 3 days past 2nd shot, 2 weeks later, complete allergic reaction, ended up in ED.  Newly diagnosed with Autoimmune Angioedema, Autoimmune Uticaria and Thyroiditis  since vaccination.
Pt/mother was asked to stay 15 mins to monitor, mother said pt was "fine" and left after 5 mins of receiving vaccine, when family reached front of clinic pt was pale and fainted as reported by parents, did not injure self, parent was able to catch pt before falling, medical staff called to front of clinic, pt awake on arrival of medical staff. Pt was then brought back to exam room where she was observed and evaluated by NP. Pt d/c'd home once stable. Pt w/hx of vasovagal - near syncope w/fingersticks.
Shortly after injection I got hot, foggy, felt like tongue was swollen.   Had problems swallowing.  I was scared, but said nothing.  It only lasted a few minutes.   About after an hour of being home, I had an issue swallowing only once.   I don't know if adverse reaction, or panic attack.  I have my 2nd dose schedule for the beginning of Feb  I will let them know what happened.   Also, quarter size red spot on right arm.   It hurt when touched.   Lasted a couple days.
Information has been received from a physician concerning a 41 year old female pt, who on 7/1/99 was vaccinated IM in the left deltoid with a first dose of Hep B. On 7/2/99, the pt developed a fever and started menstruating, which was not appropriate for her cycle. It was reported that the pt thought it was related to stress. On 8/2/99, the pt was vaccinated IM in the left deltoid with a second dose of Hep B vaccine. On 8/3/99, the pt developed a fever and began menstruating again, "when it was not due." Follow up information from a physician reported that the pt subsequently recovered.
Lost language, lost eye contact within weeks. Lack of further language and social development. Had a significant development regression that began 14-15 months of age. Developed odd, repetitive behaviors and self-stimulatory behavior. Developed chronic constipation at 14 months of age. By 9/16/98, pediatrician thought he was Autistic and he was sent to another doctor and another, who dx'd him with Autism. Doctor's exam showed he was unable to walk, had few words. Treatment: Secretin infusions; nutritional/vitamin supplements; ABA (Lovass Discrete Trial Program 40-55 hours per week); Auditory integration therapy; Greenspan Floortime Therapy; Speech therapy; Occupational therapy; Gluten and Casein Free Diet.
Patient states after administration of PNEUMOVAX she initially had no problem however during the night she began to feel pain and slight swelling at the injection site. She explained that the pain grew more severe to the point that it was so severe that she could not move her arm normally. At the time of the call she said it was improving and complained of no other system involvement at time of call explained she was improving.
didn't come come back in 8 weeks for the 2nd dose, no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown demographic patient did not come come back in 8 weeks for the second dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and had a first dose lot number not reported via unknown route in unknown administration site on an unspecified date of Nov-2018.  The patient's past medical history, medical treatment(s), vaccination(s) concomitant medications and family history were not provided.  It is an actual medication error case due to missed dose as the patient missed her second dose.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
I received the first dose of the Moderna vaccine at my workplace at 10:12am on 1/14/21 and waited the 20 minute observation period with no problems. I returned to my work station and noted a "typical" sore arm and slight fatigue. Appx. 5-6 hours later, the soreness increased significantly and was very uncomfortable. Tylenol 1300mg helped me fall asleep that night. The second day, the pain continued at the deltoid muscle and I was unable to raise my arm more than 90 degrees. The pain interrupted my ability to go about my daily activities or perform my job duties. That second night, the pain was debilitating to the point of crying and Tylenol was not helping. The third day, the severe arm pain continued and I was still in tears. I could not even raise my left arm to the level of my wait. I switched to ibuprofen with moderate success.   By the fourth day, 1/18, the pain had rescinded. I had little to no pain for the next four days (1/19/21 to 1/23/21). On Saturday, 1/23, I noticed my left arm was becoming sore again. Over the past three days, the soreness and pain have returned and have limited my ability to use my left arm. The arm pain disrupts my ability to get a good night's sleep as there is no position of comfort. When not moving, my left shoulder feels sore and uncomfortable. When moving my left arm, I feel pain when moving it in certain motions/directions. My range of motion is reduced and this along with the pain is disrupting my ability to drive my car, reach for objects and take a shower.   Because it has now been 12 days since my vaccine, I went to urgent care for help this morning. Because the pain left and then returned again, the physician determined that my mechanism of injury is not mechanical in nature, but most likely related to inflammation caused by the vaccine. She prescribed me an anti-inflammatory, muscle relaxers, and home physical therapy exercises to see if we can improve my condition. She also recommended me to file this report with VAERS.
Received my Covid shot yesterday at a Mall Testing Site.About 8pm I began having severe chills. I went to bed at 9:30pm, woke up at 1:00am and took some Motrin. This morning at 6:40 am I still had chills so I took my temperature and it was 100.0 degrees. It has remained 100 degrees this morning. I took some more Motrin. My right arm is also sore at injection site.
VERY LETHARGIC; SLEEPLESSNESS; FEVER; SEVERE HEADACHES; TINGLING EXTREMITIES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190 expiry: UNKNOW) dose, start therapy date were not reported for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient experienced very lethargic, sleeplessness, fever, severe headaches, and tingling extremities. Treatment medications (dates unspecified) included: serotonin, and melatonin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very lethargic, fever, severe headaches, and tingling extremities, and had not recovered from sleeplessness. This report was non-serious.
FEELING SICK; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced feeling sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling sick was not reported. This report was non-serious.
From initial information received on 05/28/04 from a RN regarding an adverse event occurring in the USA, it was reported that a 4 month old male pt received his second dose of IPOL, Lot # X0553-2, administered IM in the right thigh, his second dose of TRIPEDIA, Lot # U1007BA, administered IM in the left thigh, a second dose of RECOMBIVAX-HB/HEPATITIS B VACCINE, Lot # 0692M, administered IM in the left thigh and his second dose of PREVNAR, Lot # 491575, administered IM in the right thigh on 03/18/04.  An unspecified amount of time later that day, the pt developed a lump, callus and dimple like appearance at the site of injection. His pre-existing medical conditions include allergy to Omnicef and gastrointestinal irritation with bleeding. The child had a previous reaction of a lump at the site of injection when he was vaccinated on 01/16/04.  Specific vaccines administered were not provided. The pt's recovery status is currently unknown.
Immediate pain in left arm/shoulder. Within 5 min, I walked to lobby, had tingling and itching in soles of feet, a "rush" through body, resulting in headache, throbbing backache at waist and below. Iced neck, back. Flu like aches lasted 48 hours. ADVIL helped.
headache; couldn't pick up my arm, that lasted for a day; This is a spontaneous report from a contactable consumer (patient, self-reported). A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on 09Jan2021, as a single dose for COVID-19 immunization. Patient's medical history included high blood pressure. Concomitant medications were not provided. The patient reported that after he got the shot, on an unknown date in Jan2021, he couldn't pick up his arm, that lasted for a day. The next week, he got a headache, and he didn't get headaches. He would get a slight headache every now and then, off and on for 3 or 4 days above his eyebrow. He took Tylenol and it went away. He heard that he would get really bad side effects with the second shot and he was just concerned. Patient's second dose was scheduled on 29Jan2021. Outcome of the event was recovered on an unknown date in Jan2021.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Belles Palsey; paralysis rt side of face; rxn given pred; iritis both eyes; 1 week p/Bell's palsy, Rx given, referred to MD;
A territory representative reported that a 7 month old male received his 1st dose of Prevnar in 3/01. Five days, post vax, he developed generalized urticaria. On 3/13/01, he was seen by the physician and treated "symptomatically". No further information was available at the date of this report.
pt started crying just p/leaving the clinic; pt cried nonstop until 1AM; when fever broke; had a fever throughout the day; when seen @ ER temp was 104.9 R; pt was staring & moaning when not crying;
Redness at site of vaccine with an area about one inch radius of point of insertion. Itchiness at site of vaccine. No treatment sought.
This case was reported by a nurse and by a vaccines responsible physician and described the occurrence of injection site redness in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included PROQUAD (Merck; unknown route and injection site) given on 28 March 2014. On 28 March 2014, the subject received the last dose of KINRIX (.5 ml, left thigh instead of upper arm, unknown route). On 31 March 2014, 3 days after vaccination with KINRIX, the subject experienced injection site redness which led to a maladministration (vaccine administered at inappropriate site). Several doses of the caps of the vaccine were loose in the box; the doses of KINRIX with the loose tops were discarded but the remaining doses in the box were used for this subject. The reporter was unsure if the other doses used were safe to have used. The subject's grandmother will continue to watch it and will call back to bring him if needed. At the time of reporting, the outcome of the event was unspecified. This case is one of the two cases reported by the same reporter linked to A1067555A. This case was associated to a product complaint. Conclusion regarding the complaint, received on 17 April 2014: According to the thorough investigation performed at the different production steps, and the observation of the returned samples, GlaxoSmithKline Biologicals considers this complaint as unsubstantiated.
Tingling in arm after injection, like arm fell asleep, lasted a couple of hours.  Later on night of injection, had severely swollen and painful lymph nodes under arm on side of vaccination.  Vomiting, nausea, headache all over head next day.  Nerve pain/sensitivity in back, all along spine.  Fever/chills, muscle spasms in back, hip joints ache.  All lasted approx. 48 hours except lymph node swelling and pain, headache and nerve sensitivity of which are all ongoing.
Started with tingling in arms and hands, then chest pain started. Chest pain has gotten worse. Headaches that travel around head, zapping pain throughout body, stomach issues, tachycardia, shortness of breath, abnormally cold hands and feet,  and brain fog.
Approx1255: Patient stated he was not feeling well, light-headed.  Patient pale, sweating.  He asked to lie down.  Encouraged to take deep breaths.  Patient asked to step outside of room, assisted to hallway chair for air.  Wife at side, encouraging to take deep breaths.  Patient stated he could not see us and slumped in chair with eyes open and glazed.  Shallow breathing, unresponsive to sternal rub.  Lips noted to turn purple-blue and then gray.  Called for assistance and LVN at patient side obtaining VS, patient took deep breath and started to become responsive.  VS at approx. 1303: BP104/47, HR 57, 02 Sat 95%.   Patient talking, continued pale and diaphoretic.  911 called and EMS arrived at approx. 1305  Transferred to  hospital.
dizziness patient feels his heart beat increased.  BP: 126/68 for few secs.   Patient stayed in observation area for 30 minutes.  -advised him to drink fluids -patient feels better after 10 minutes and left for home when observation period over.  -patient stated he had same symptoms from 1st dose too.  - advised patient to consult PHP if symptoms persist.  - patient stated PHP is aware of symptoms from 1st dose.  Vitals: BP:110/72    Pulse 72 o2-99%  Patient stated these are his baseline vitals. He feels better - no more symptoms.
This spontaneous report was received from a certified medical assistant refers to an unspecified patients of unknown age. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored RECOMBIVAX HB 1048236, 31-MAR-2018. No adverse events were reported. Temperature of 49.3 F for 24 hours and there was no previous temperature excursion. This is one of the 4 reports received from the same reporter. Additional information has been requested.