chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse reactions other then pain in the injection site and being tired then last night 48 hours later my eye was twitching.  Today it 72 hours later eye twitching again and then this afternoon my bottom lip began to tingle.   Called the Urgent care they said come in and I did and the said it is bells palsy and gave me steroids and another drug to take
Information has been received from a lawyer regarding a case in litigation concerning a female (age not reported) who, on an unspecified date, was vaccinated with a dose of Pneumovax 23.  Subsequently, the patient "contracted a reaction in her arm".  She was administered the vaccine by a nurse.  The patient "complained of her arm being red and swollen."  No further information is available.
Patient got flu shot around 2pm and left the pharmacy area to continue shopping with her mother. Approximately 2 minutes later the mother had returned with her daughter and said that her daughter was having difficulty breathing. The patients face was very red and she was crying. I had them sit in our patient lounge area and directed my technician to call 911. I grabbed my emergency kit, and the BP machine was not working correctly so I took the patients pulse, which was 80 bpm. She started to calm down and said breathing was getting easier. I noticed 1 small hive on her forehead which was not present when I administered the vaccine. I continued to monitor the patient as we waited for paramedics to arrive. As her breathing was getting easier and she had a good pulse I did not administer any adrenaline. When paramedics arrived they looked elsewhere on her body for hives, but only found the single one that had appeared on her forehead. They decided to take her to the emergency room for further monitoring.
This case was reported by a physician (an allergist) and described the occurrence of local reaction to flu vaccine in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX (2009 vaccine). At an unspecified time after vaccination with FLUARIX, the subject experienced local reaction to flu vaccine. The physician reported that the subject received the 2009 FLUARIX vaccine and experienced a large localized reaction. At the time of reporting the outcome of the event was unspecified. The lot number was reported as AFLUAS00BA from the reporter; however based on a safety lot number review, the lot number was updated to AFLUA500BA.
6/2015 developed hypocalcemia (ionized calcium 0.76) with muscle spasm - admitted to hospital for IV calcium.
Starting on 05/06/2022, I woke up with a slight scratchy throat, terrible headache and a metallic taste in my mouth which lasted for 2.5 days, and I haven't been sick in this entire COVID pandemic. So, I took a home test from the pharmacy and I was positive. I contacted my PCP and received a PCR test which was also positive. My PCP put me on Paxlovid, and after the first 2.5 days i recovered quickly. I stayed isolated  for the recommended time and am still kind of isolated for safety. I still have a residual cough and congestion but I think that's related to allergies because it doesn't feel the same as when I was sick. During the episode, I was very lethargic and fatigued, but not currently. Also, I did not have a fever that I can recall.
Information has been received from a physician concerning a 35 year old pregnant female who was exposed to a child who was vaccinated with MMR and subsequently, the pt experienced mild, pruritic red bumps on her abdomen. The physician noted "she has no fever and feels well." On an unspecified date, the pt recovered. No further information is available.
Physician ordered flulaval on patient but was administered Prevnar 20 instead. Nurse advised and physician of incident. Patient was made aware while still here in the office.  When nurse reported it was found that proper second check was not completed. Both physician and nurse are new to the office. Education was provided again to both physician and nurse regarding the proper second check protocol. Patient refused flulaval vaccine.
Menveo only liquid portion; Menveo only liquid portion; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA935A) for prophylaxis.   On 14-JUL-2023, the patient received Menveo. On 14-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo only liquid portion) and inappropriate dose of vaccine administered (Verbatim: Menveo only liquid portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 19-JUL-2023 Nurse calls to report only the liquid portion of Menveo was administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email agreed.
Approximately 8 hours after getting shot, arm started aching heavily; the achiness migrated to neck, back and left shoulder blade; had a mild headache.  Slept from 9:30-8:30. On Tuesday, May 4, woke up feeling like I had indigestion.  After being up a few hours walked to get groceries.  The achiness came back. Took a long hot bath; felt better but a couple hours later got tired and developed a fever.  My temperature was 100.5°F at 5:40 PM, 101.2 °F at 7:23 PM, 101.5°F at 8:30 PM, and 101.1 at 9:30 PM.  Fever broke around midnight.  Temperature was 97.2°F at 12:10 AM.  After fever broke extremely bad tinnitus started, loud enough to keep me awake until around 4:30 in the morning.  White noise, buzzing was still there
Heart pounding occured once in the afternoon day of vaccine, then over the next 2 days.
feels discomfort even touching her eyelashes; pain in the back of an eye; she could not sleep due to the eye pain; soreness in her arm; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 22Mar2021 (at the of 65 years) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 22Mar2021 the patient experienced soreness in her arm. On 24Mar2021 pain in the back of an eye, she could not sleep due to the eye pain, feels discomfort even touching her eyelashes. The outcome of the events was soreness in her arm recovered on 23Mar2021, pain in the back of an eye not recovered, she could not sleep due to the eye pain, feels discomfort even touching her eyelashes unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Shortly after receiving the 3rd dose of GARDASIL 4, my son developed allergy like symptoms in the sinuses. Sinusitis developed in September, which was incurable no matter what we tried (CLARITIN, Nasal Wash, BENADRYL). BENADRYL). By October patient experienced his first bout with high fevers and enlarged lymph nodes in the neck (cervical), accompanied by terrible sore throat, neck pain at the base of the head and lower back pain. This lasted for 4 days - 104 days-104 degree fever, chills, exhaustion, loss of sharp thinking. He stated he felt like his head was going to explode and he said he felt as if he wasn't as smart. This pattern of sickness came again - 6 weeks to the day in November, in December, and every 6 week weeks now for a year. We removed his tonsils, biopsied them no cure. We have tried prescription allergy medicine, homeopathic aids- such as arm and hammer wash, but he is still getting symptoms every six weeks to the day.
Initial unsolicited report received from a consumer (patient's mother) on 9 October 2015. This case is linked to 2015SA160781 (same reporter, different patients). This case involves a male patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Influenza vaccine) (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination, the patient experienced cold and cough symptoms. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Patient received for her first 2 covid 19 vaccines the Pfizer vaccine. But she had systemic reactions to both of those doses. So an allergist recommended that she get the J&J vaccine for her booster dose. 5 minutes after recieving the dose she had generalized itching.  PO Benadryl given;  then about 10 minutes after that the symptoms worsened to wheezing, coughing, throat tightness and swelling.  Epi IM given.
Approximately 5 minutes after receiving first dose of Pfizer covid vaccine c/o left arm itching at the injection site. Injection site warm, red and tender to touch with redness extending from below injection on deltoid to shoulder. Macular rash did not extend beyond upper arm and shoulder, not noted on back or chest. Denies nausea, dizziness, throat constriction or difficulty breathing.   Treatment - Ice appled to macular rash for 20 minutes with re-application after 5 minutes.  Redness significantly decreased on arm and shoulder after 40 minutes.  Injection site red and warm to touch, arm and shoulder cool.   Patient observed for 60 minutes then discharged with instructions to apply ice  x 20 min and take diphenhydramine at home, and to go to the ER if symptoms get worse.
Patient reports rash underneath the injection site. Localized reddness the size of palm of hand. No itching, pain, pustules, or soreness. Rash started 24 hours after vaccine administration. She describes reaction as mild and has no prior reactions to flu vaccine in previous years. Followed up with patient on 10/16/17 and the rash has completely gone away.
temperature excursion; This spontaneous report was received from a Healthcare Professional (HCP) and refers to a 5-month-old male.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-DEC-2022, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892784, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength and dose was not provided) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W006596, expiration date: 11-OCT-2024, administered intramuscularly in left thigh for prophylaxis (strength and dose was not provided) (product storage error).  On 01-DEC-2022, administered doses of vaccines experienced the temperature excursion of 47.9 degrees Fahrenheit for 47 minutes.
12 days postoperative liver transplant done at the facility on 11/22/2021. He presented to the ED on 12/4/2021 with left leg swelling, substantially improved on a 5 day course of Lasix however not completely resolved. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
pt recv vax; 1 wk p/ MMR fever of 104.2 & rash starting on face going down; ER MD felt high fever & rash were from immunization;
Information has been received from a physician concerning a boy who was vaccinated with VARIVAX (Oka/Merck) 0.5ml (therapy started date, route, site unknown) and experienced wheezing at some unspecified time after receiving the vaccine (past few weeks). The patient sought medical attention and treatment was unknown. At the time of report patient had recovered. Additional information has been requested.
Moderna first Dose Vaccine give 09/23/2021.  Lot later found to have expired 09/22/2021.   Moderna contacted, all handling details given,  Moderna tested viability of vaccine lot beyond expiration and found it maintained the activity necessary to protect against Covid 19 at the time of administration.  No adverse reactions related to this to patient found.
Bell's Palsy; painful rash on her side; balance issues; vision problems; slurred speech; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around January 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered a painful rash on her side, balance issues, facial weakness and paralysis, vision problems, and slurred speech. The patient was diagnosed with Bell's Palsy. The aforementioned injuries, which resulted in hospitalization, were caused by zoster vaccine live (ZOSTAVAX). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered not recovered/not resolved. The events were considered related to zoster vaccine live (ZOSTAVAX).  Upon internal review, Bell's Palsy were determined to be medically significant. The reporter considered all the events to be disability.
No additional AE; Patient was administered Improperly Stored ROTATEQ and PEDVAX HIB; This spontaneous report was received from a nurse referring to a 4-month-old patient on unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 29-OCT-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 1 dosage form, lot number S040483, expiration date 19-JUN-2021 and haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 1 dosage form, lot number T000886, expiration date 29-MAY-2022 (route of administration was not provided for the vaccines). Both for prophylaxis.      The vaccines underwent a temperature excursion above 9 degrees Celsius (°C), with an average of 9.7°C for 45 minutes. There were no previous temperature excursions. The call was due to digital data logger. ; Sender's Comments:  US-009507513-2010USA012181:
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 20-JAN-2017, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
This is a spontaneous report from a contactable consumer, a Pfizer sales representative, who reported himself. A 51-year-old male patient received a single dose of PREVNAR 13 for prevention of pneumococcal on 13Feb2015. Concomitant medications and medical history were not reported. On 19Feb2015, the patient experienced a baseball size red rash, a raised area that spread at the site of injection that's about the size of a baseball. The event was never reported to the physician. The clinical outcome of the event was resolved without treatment. Follow-up (10Mar2015): New information received from the same contactable consumer includes: treatment (NOS) and outcome (recovered). Follow-up attempts completed. No further information expected.
Continuous daily chills, sore throat and lethargic for 11 days after 2nd vaccine
This spontaneous report has been received from a 80 year old female patient refers to herself. Patient's medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot number, dose and route were not reported). The patient stated that she still developed shingles (unknown date). At the time of the report the outcome of the event was reported as not recovered/not resolved. Additional information is not expected as no patient's or physician information was reported.
Chills; Headache; Pain in her arm/arm is sore; joint pain; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team and also from a Pfizer Sponsored Program . A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/lot number: Unknown) via an unspecified route of administration on 26Jan2021 at 30 ug, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the patient received the first dose of the COVID vaccine on 26Jan2021. Her next appointment was scheduled 23Feb2021 (10 days in addition to 21 days). The patient had headache, chill and pain in her arm/arm is sore and joint pain after the first dose of COVID vaccine in Jan2021. Caller stated her chills have went away but was still getting a little bit of a headache and she had some pain in her arm in Jan2021, but it was much better now. The patient got the shot on the 26th and was given her second shot on 23Feb2021. The outcome of the event headache was not recovered, pain in her arm was recovering, chills was recovered on an unspecified date in 2021 and joint pain was unknown.  Information on the lot/batch number has been requested.
On the same afternoon of the injection,  (Sunday, April 18, 2021 at 9:15am), at the site of injection in the upper right arm, site was hot and hard to the touch and extremely itchy.  Symptoms lasted through the rest of Sunday and all day Monday, April 19, 2021.  Waking up Tuesday morning, on April 20th, all symptoms were gone.
Patient contracted COVID-19 8 days after administration of 2nd dose of Pfizer COVID-19 vaccine - confirmed with nasal PCR
All her doses of the covid vaccine were manufactured by Pfizer, she had 4 total doses/covid positive after 4 doses of Pfizer covid vaccine; All her doses of the covid vaccine were manufactured by Pfizer, she had 4 total doses/covid positive after 4 doses of Pfizer covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  An 84-year-old female patient received BNT162b2 (BNT162B2), in Jan2020 as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "All her doses of the covid vaccine were manufactured by Pfizer, she had 4 total doses/covid positive after 4 doses of Pfizer covid vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: covid positive after 4 doses of Pfizer covid vaccine. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Paxlovid started on 11Nov2022 indication was covid positive. She had all her booster shots. She thought her first dose was in Jan2020. All her doses of the covid vaccine were manufactured by Pfizer, she had 4 total doses. She was positive after 4 doses of Pfizer covid vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a consumer referring to her 5 year old daughter.  Information about pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medication was not reported. On an unknown date, the patient was vaccinated with the second dose of M-M-R II (dose detail, route, lot # and expiration date were not reported) for prophylaxis. On 30-NOV-2018, after received this second dose of M-M-R II, the reporter stated the patient experienced a low grade fever. The reporter will speak with pediatrician later in regard to the fever of the patient. The outcome of event was reported as not recovered. The causality assessment between event and M-M-R II was not reported.
Spontaneous miscarriage after 2nd dose and 3rd dose. I previous history of infertility. Two healthy pregnancies prior.
manic activity, purpura, dissociation, rash on trunk and perioral, ankles, fever
A lymph appeared below my neck During my routine check-up a week post-vaccine my THS4 Thyroid levels dropped to 0.006
My arm went completely numb immediately and then it started itching and then about an hour later my throat started to close and I could see my heart beating out of my chest and I ended up having to go to the emergency room and then over the next three weeks I have experienced every side effect that is listed  With the worst being fatigue muscle ache and abdominal cramps
Patient has hives to upper extremities, itching, throat scratching and vomiting s/p receiving flu vaccine within 30 min.
got shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-JUL-2023 This case was reported by a patient via interactive digital media. It was reported that the patient got the Shingles shot and 2 weeks later got shingles. The follow up could not be possible as no contact details were available.