chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BLOOD CLOT; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age, race and ethnic origin. 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, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 in total administered for covid-19 prophylaxis. 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 patient experienced blood clot, and was hospitalized (date unspecified). It was reported that, the patient had blood clot and rushed to the hospital and the surgery was performed. The number of days of hospitalization was not reported and it was unsure if the patient was discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20230201840-blood clot.The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
The right side of my tongue and face started to swell after 20 minutes my face and tongue went numb. I called 911 The paramedics came out just to make sure that I was not having a stroke. They did advise me if I did not feel any better to step in to the hospital at 5 PM.
After the first shot, I suffered from daily migraines for a week. I took Motrin to help with the migraines.  After the second shot, half my body broke out in hives the next day. My doctor prescribed a prescription antihistamine. The hives went away after a few days.  A few days after my second vaccine, I got my period. My period lasted for close to a month. My doctor prescribed me Provera to stop my period. Provera finally stopped my period.  Starting 12Jul2021 I got my period and now on 26Jul2021, I still have my period with horrible cramps. My period was light in the beginning, but starting 23Jul2021, my period started getting very heavy. I reached out to my doctor to see if I need another round of Provera to stop my period.
pt stated that he developed chills within the first couple of hours after rcvg vax that lasted for over 2 weeks before they started to improve.  He still infrequently gets the chills from time to time.  He contacted his PCP to let them know of his symptoms.
Tongue numb, prickly a bit swollen, face felt off. Tingling and numbness all the way down arm and into fingers, also tingling and numbness from underarm to halfway down waist.
This is a spontaneous report from a Pfizer-sponsored program COVAX US SUPPORT. A contactable consumer (patient's wife) reported for a male patient (husband). A male patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 10Feb2021 as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient experienced sore at the injection site on an unspecified date. The reporter would like to know if she can take Tylenol or Naproxen. The outcome of the events was reported as unknown. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
left lateral thigh with 3cm area of bruising and ~1cm surrounding induration. There is a faint fading area of erythema around this area 5cm x 5xm, barely visible (where redness was yesterday per mom and photo she showed). No fluctuance. Mild tenderness.
Patient received adult Pfizer monovalent COVID-19 vaccine as a dose in his primary series instead of the authorized for his age group Pfizer monovalent COVID-19 vaccine 5-11 years.  Parents notified via letter 3/15/2023.
Patient had a COVID booster on Friday and over the weekend she reported pain, swelling, tenderness, redness that was worsening and spreading. Staff reports that a circular area on her left upper arm/shoulder seemed to be growing larger, similar to cellulitis. Staff cautiously watched this area for signs that the area was worsening. They also drew a line demarcating the edge of the area of concern. Patient did not report any other abnormal symptoms or feelings following this booster shot.  Today, the area of concern has not progressed much beyond the drawn line. She also reports that the area is improving. She denied having any other symptoms; no f/c/n/v/d/c, has, vision changes, abdominal pains, dysuria.
Pink rash at the injection site about 6 inches long and 3 inches wide. Very itchy, warm and  pain when touched. It was swollen as the days wore on.
Customer stated she had a pinkish solution that soaked her band-aide. She noted this after she went to remove her band-aide after she got home. She had no pain with the injection and did not note any liquid that ran down her arm after the injection
A registered nurse provided information regarding 13 students who on 04/19/1999 received vax, SC in right arm with MMR. Also received DT, IM in the left deltoid. It was indicated that one of the students received the 3rd dose of MMR, while the rest of the students received their 2nd dose. Within 2-3 hours post vax, the student experienced feeling extremely tired, malaise, headache, stomach ache, nausea and dizziness. They also experienced injection site pain in their left deltoid. The nurse noted that the students were extremely pale. It was noted that one of the students went home ill that same day and returned well the next day. In addition, "all the students who returned to school the next day had no complaints." One stayed home the next day due to sore arm from DT. Another was hospitalized with dehydration from a virus. The reporter noted in the follow-up that all the students who returned to school the next day recovered from symptoms. She stated that she "did another MMR and TD at 2 different schools to 6th grades, 04/20/99 & 04/22/99. None of the students complained of any type of reaction." No further details were provided.
I received the second dose on 1/21/21 at approximately 2:15 pm, the next morning I woke up to a welt at the injection site along with extreme sensitivity to touch. The site also is red about an inch in diameter around the site. Pain is being treated with ice compress as of now.
Patient received his first Moderna COVID vaccination and went and sat down in front of the pharmacy. About 5 minutes after his shot, a woman walking by heard him say he felt like he was going to pass out and caught him as he was falling out of his chair. Staff member heard the commotion and immediately got my attention. I instructed him to call 911 and went out to the patient. As I got to the patient he was beginning to regain consciousness. The woman said the patient had hit his head on the shelving that was behind the chair. I gave him some water and had him stay seated until EMS arrived. EMS checked him out and released him into the care of his family.
No adverse event but an administration error. Patient received the Pfizer Bivalent vaccine as her first dose instead of the monovalent.
Besides some known symptoms like headache, chills, low energy, there was a marked increase in neuropathy pain that seemed unusual despite the medications for this condition: Lyrica 100mg during the day and 300mg at night, and Dronabinol 5mg at night that usually control the pain.  This started kicking up during the day after the shot (04/09/21) progressively getting worse during the day with full blown episodes of pain into the evening and night.  This stopped about 3:00am.  I did not think it was related to the second covid shot until the next day when I looked for kn I was symptoms of the shot and found a blog where several people had also noted this symptom.
This patient received their second dose of pfizer as a walk in on 5/14.  However the patients first dose was given at another pharmacy which was a Moderna site.  All staff involved with this patient have been re educated on the importance of checking first dose details before administering 2nd dose, especially for site to site walk ins.  Date of first dose 3/16/2021 ? Left Deltoid First dose site Pharmacy First dose lot number Moderna 074A21A First dose expiration date not noted
Case number PHEH2013US016745 is an initial spontaneous report received from a nurse on 06 Aug 2013. This is also a quality complaint report (reference number: 238867). This report refers to a 24-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with RABAVERT (batch number: 473011C) at a dose of one ml, intramuscularly, with first dose on 07 Sep 2011 (day 0) at right deltoid, second dose on 14 Sep 2011 (day 7) at left deltoid and third dose on 05 Oct 2011 (day 28) at left deltoid. On 15 May 2013, he had equivocal rabies titer, which was an insufficient result. He required a booster dose of rabies. Reporter assessed the case as serious (significant). No other information was provided.
A report has been received from a Health Professional concerning a 36 year old, male subject, who had been receiving Nasal FLUMIST.  FLUMIST started on 29-AUG-2013. It was reported that FLUMIST was administered and inadvertently squired in patient's right eye which started on 29-AUG-2013. The outcome of th event of inadvertently squirted in patient's right eye is unknown. The report was considered to be non-serious. Correct report 11-SEP-2013: Case was medically conformed by replacing consumer with Health professional.
PATIENT NOTED TO HAVE SYNCOPAL EPISODE AFTER WALKING OUT OF EXAM ROOM AFTER  VACCINES, PALE IN COLOR, UNRESPONSIVE FOR APPROXIMATELY 5-10 SECONDS,NURSE THEN ELEVATED LEGS  , THEN REACTED TO HIS NAME AND TALKING COHERNTLY.B/P 99/63 HR 96 RETOOK  BP APPROX 5 MINS LATER WIT HBP 101/64 HR 102. PATIENT ABLE TO ANSWER QUESTION  CORRECTLY, ABLE TO DRINK WATER ,DENIES PAIN,  STATES FEELING BETTER, AFTER  APPROXIMATELY 20 MINS PATIENT ABLE TO WALK OUT OF CLINIC WITHOUT ANY DIFFICULTY.  MOTHER AT SIDE, INSTRUCTED MOM IF PT HAS ANYMORE PROBLEMS CHILD SHOULD BE SEEN  IN ER. DR CALLED AND MADE AWARE OF SITUATION WITH NO FURTHER ORDERS.
cannot stand up; vertigo; balance issue; legs are weak; heavy head, pressure in head, foggy head; shakiness and tremors; dizziness / being dizzy to walk; headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (cannot stand up), VERTIGO (vertigo), BALANCE DISORDER (balance issue), MUSCULAR WEAKNESS (legs are weak) and FEELING ABNORMAL (heavy head, pressure in head, foggy head) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Patient had no allergies and no health conditions. Concomitant products included FISH OIL, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMIN C [ASCORBIC ACID] for an unknown indication. On 08-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Oct-2022, the patient experienced DYSSTASIA (cannot stand up), VERTIGO (vertigo), BALANCE DISORDER (balance issue), MUSCULAR WEAKNESS (legs are weak), FEELING ABNORMAL (heavy head, pressure in head, foggy head), TREMOR (shakiness and tremors), DIZZINESS (dizziness / being dizzy to walk) and HEADACHE (headache). The patient was treated with MAGNESIUM at an unspecified dose and frequency and VITAMINS NOS at an unspecified dose and frequency. At the time of the report, DYSSTASIA (cannot stand up), VERTIGO (vertigo), BALANCE DISORDER (balance issue), MUSCULAR WEAKNESS (legs are weak), FEELING ABNORMAL (heavy head, pressure in head, foggy head), TREMOR (shakiness and tremors), DIZZINESS (dizziness / being dizzy to walk) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Low. On an unknown date, Computerised tomogram: Normal.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that Patient took 1st dose on 10-Mar-2021 and Lot number-029A21A, 2nd dose on 07-Apr-2021 and Lot number 030B21A, 1st booster dose on 16-Dec-2021 and Lot number 069F22A. Doctor told patient to take vitamins and magnesium and it got patient so dizzy. Magnesium causes more dizziness.
Felt tachycardic, BP 143/55, pulse 82. Stabilized with water- discharged to home.
pt rt arm was red, warm to touch and very itchy, per Nurse Practitioner take oral Benadryl to help with itchiness and apply cold compress
red swollen LLT-started vomiting last evening; vomited all noc-quit vomting 6AM; t99.4 13APR94;
16 yo given pediatric dose for booster.  Family and MD notified.  NO additional action needed.
Patient presented today with a roughly 2 to 3 inch diameter area of redness/bruising at the injection site. Patient stated that he had already been evaluated by a physician who did not display any concern. No treatment was recommended other than ice and rest. Patient stated that the worst of the symptoms had developed by midnight of the night of injection and have improved slightly since then.
Large rash at injection site- about the size of a softball or grapefruit. patient was unsure of exact day/time that rash started. Rash felt warm to the touch and itchy. She also reported pain and discomfort at injection site.
L arm injection site pain, lasted 14-24 hours. Had tested positive for covid 2/2021 Narrative:
I ached a little bit & had a fever I took Tylenol & rested & it lasted about a week.
That night and the following night I ached all over and the injection site was very sore. I ran a low-grade temperature. The second morning after the injection I went to the bathroom and nearly passed out. I was nauseated, in a cold sweat, and couldn't stand up for fear of fainting. I spent the day lying on the couch. I sipped water but had no appetite. I felt as though I had the flu, and this lasted for five days. I had to cancel appointments. I was told to get the booster; however, I'm afraid to do that.
Dose 1 - arm a little sore one day Dose 2 - arm very sore, hard to move for 1 week, mild flu-like symptoms (fatigue, headache, achy, icky) next day, brain fog ever since 2nd dose for 1 month now
Same day post vax, the pt developed emesis. She was seen by a physician and dx with dehydration. She was admitted to the hospital and was treated for 2 days due to her persistent vomiting.
Patient reported tongue swelling, start of throat swelling. Vitals obtained and rapid response team called to evaluate. Patient transferred to ED for further evaluation/ treatment.
Tingling in legs from knees down.  Can feel slight throbbing in calves and front of legs below knees. Has gotten worse in week 3.   I?m making a Neuro appt next week.
New symptoms not previously experience since date of vaccine started 7 days after: itching , redness,warmyh, swelling 3inches by 3 inches
Late July 2021 I had a bartholin gland infection and also a miscarriage around 6 weeks the first/second week of August.  The bartholin gland infection required antibiotic treatment and an incision to drain.  I don't think either of these are related to the vaccine, I just noted these issues because the questionnaire asked about health issues that I have experienced since my last check in, so I'm filling out the report as requested.  I have fully recovered from both issues.
flu like symptoms; lost 16 lbs due; nash; "fatigue is not as bad"; less pain in r hands/pain in feet; swelling in hands/swelling in feet; pain in wrists/elbows/pain in knees/ankles/pain in hips; pain in shoulders; pain in neck; swelling in wrists/in elbows/in shoulders/in knees/in ankles/in hips; swelling in neck; This case was reported by a pharmacist via other and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included tofacitinib citrate (Xeljanz).   On an unknown date, the patient received Shingrix and PNEUMOVAX. On an unknown date, less than a month after receiving Shingrix, the patient experienced influenza-like symptoms, weight loss, rash, fatigue, pain in hand, hand swelling, wrist pain, shoulder pain, neck pain, swelling of wrists and neck swelling. On an unknown date, the outcome of the influenza-like symptoms, weight loss, rash, fatigue, pain in hand, hand swelling, wrist pain, shoulder pain, neck pain, swelling of wrists and neck swelling were unknown.   It was unknown if the reporter considered the influenza-like symptoms, weight loss, rash, fatigue, pain in hand, hand swelling, wrist pain, shoulder pain, neck pain, swelling of wrists and neck swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received shingrix and pneumonvax vaccinations a couple of weeks ago and had flu like symptoms that lasted 2-3 days.  The patient has recovered. The patient lost 16 lbs due to a recently being diagnosed with rash, patient had cholesterol checked 2 weeks and hepatologist was monitoring blood levels.  The patient mentioned all team of MDs had great communication.  Since starting therapy, the patient had not had any side effects noted fatigue was not as bad and had some minor improvements with less pain and swelling in hands, wrists, elbows, shoulders, knees, ankles, feet, neck, and hips on occasion.  The patient would get discouraged but had a great support from friends.  No further information or side effects provided by the patient.
swollen eye; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 02Jun2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 03Jun2021, the patient woke up with swollen eye. Something similar had never happened to him and he wants to know if it is something reported with the vaccine. Referred to his physician for treatment recommendation. The outcome of the event was unknown.  Information about lot/batch no has been requested.
Got 2 shots, experienced it/Suspected vaccintion failure; Shingles, shingles pain; Worst pain/ feeling the nerve pain; Itching; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve pain and pruritus. The patient was treated with gabapentin. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, nerve pain and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, nerve pain and pruritus to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 16-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient reported that the shingles shots could not protect us from shingles because he/she experienced them. The patient had 2 shots of shingles vaccine until now he/she was feeling the nerve pain and itching. The patient mentioned that it was been 8 months and it was the worse pain that you could imagine giving birth was nothing compared to shingles pain.  The patient mentioned that the correct dose of gabapentin helped him/her so much. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Immediately following my second shot, I had a fever and didn't feel well for about 24 hours. I think unrelated to the vaccine, about 7 weeks after the second shot,  I had a terrible head cold and cough.
This spontaneous report was received from a physician and a healthcare worker concerning an unknown number of patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On 21-MAR-2016, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # L048236; expiration date: 32-MAR2-18 and lot# L048849; expiration date: 04-FEB-2018) (dose and route not provided). The patients' concomitant medications were not provided. No adverse effects were reported. It was reported the following temperature excursion for the administered vaccines: 18 degrees C for 22.5 hours. No previous temperature excursion was reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a medical assistant referring to a patient of unknown age and gender. No information of pertinent medical history, drug reactions/allergies and concomitant medication were provided. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX, (lot # M010472, expiration date 01-JUN-2017, strength, dose and route were unknown). No adverse effects was reported. It was unspecified if the patient sought medical attention. This is one of two reports received form the same source. Additional information has been requested.
Adult Td. was admisistered on 8-27-02.  on 8-29-02 patient developed a swollen lower lip and urticaria on his right forearm, which shortly disappeared.  On 8-30-02, he developed the same symptoms.  He saw his personal physician and was treated with diphenhydramine and an antihistamine. It is unknown whether his allergic reaction was caused by the Td. injection.
Per pt's report: She went home after receiving her vaccine and took some TYLENOL about 9:30 pm. She was awoken by shaking chills at 2:00 am. This lasted until about 5:00 am. She proceeded to go to work but felt nauseous and dizzy ("almost passed out"). She felt much better toward the end of the day and back to her normal self the following day.
For 3 days after vaccine, patient experienced high blood sugar levels. No changes in diet or lifestyle. No prior acute illness.
Lightheaded, shaky; B/P-135/78, P- 78, pulse ox- 95%; cleared by onsite nursing supervisor Client reports past history of fainting with blood draws
Pt received 2nd dose of Shingrix on 2/15 (Sat) on 2/16/2020 she noted erythema of (L) arm 1-2 Cm below inject site & some mild discomfort. Has been applying ice & Ibuprofen without change. No fever. Seen by MD 2/18 area was marked & advised to continue with ice and not to take any fever reducing medication to ensure she is not having fevers