chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II lot # M029919 and expiration date 13-JUN-2018 (dose, frequency and route of administration were not reported) for prophylaxis. There were no adverse symptoms reported Administered doses of vaccine experienced the temperature excursion from 47 to 77 degrees Fahrenheit for 34 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA005381: US-009507513-1709USA005380: US-009507513-1709USA002048: US-009507513-1709USA005379:
G47.33 OBSTRUCTIVE SLEEP APNEA 8/8/2023 DELIRIUM
3 pm fussy. 5 pm MOTRIN. 7 pm large emesis. 8 pm shivering. Twitching of (L) arm. Small emesis. 11:30 pm fussy. MOTRIN. Next day - without problems.
This case was reported by a pharmacist and described the occurrence of lingering headache in an elderly female subject over the age of 70-years-old who was vaccinated with BOOSTRIX (GlaxoSmithKline). On or about 10 November 2013 at 11:00 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown). On an unspecified date in November 2013, within weeks of vaccination with BOOSTRIX, the subject experienced mild lingering headache. The pharmacist stated that the subject was over 70-years old and received BOOSTRIX because she was going to visit younger relatives and wanted to have pertussis coverage. The pharmacist stated that the vaccine was administered 12 days from this report (approximately 10 November 2013) and the headache still exists. The pharmacist believes it is probably related to BOOSTRIX because the subject does not have allergy or sinus problems. Specified details regarding the vaccination (lot number, expiration and subject details) were not available at the time of the report. At the time of reporting the lingering headache was unresolved. The pharmacist considered the event was probably related to vaccination with BOOSTRIX.
Information has been received from a physician concerning an unspecified number of patients who had no adverse reactions reported with GARDASIL vaccine (yeast) (MSD) (LOT# was unspecified) except for some tingling at the injection site. The physician did not specify the number of patients who had tingling. It was not reported if the patients sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Patient was hospitalized on Oct. 12, 2021 for COVID-19 related symptoms. This is classified as a breakthrough case.
Sensation of throat closure, wheezing, delayed cap refill and compensated shock. Was given an albuterol treatment and epi (10:33 AM). Transported to local hospital.
Noticed rash of red bumps spreading on left side, waist level, the itched but more burned.  Was not sure if possible Poison Ivy, which was highly unlikely, or perhaps shingles, which I had had 2x earlier many years ago. Called Dr.'s office and was told to come in so Dr could look at rash.  She was unsure at first but thought most likely shingles. She said there was a yellowish liquid seen in pustules and prescribed both a hydrocortisone cream and Valcyclovir.  Dr. said that if next day  it is more painful than itching it is most likely Shingles.  Area much more painful and Valcyclovir started. A week later  red marks drying up, but pain is still significant across left side.
Received his first MENACTRA vaccine at  11-12 years old. The second one was given two months prior to his 15th birthday with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional.    This case involves a 14 years old male patient who received his first dose at 11-12 years old and the second 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U5866BC and expiration date was not reported) via intramuscular route in the left arm for prophylactic vaccination was given two months prior to his 15th birthday (extra dose administered) on 13-Apr-2018.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9).  It was a case of actual medication error due to extra dose administered (latency on same day).  At the time of report, 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 holders 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.
On day 2.  Sever sore arm.  Sever headache,  Chills, 100.8 fever,  Very tired, Every muscle in my body hurt,  I took 3 advill    This lasted all day.  Next day symptoms were almost gone.
maternal exposure during pregnancy; Fever; chills/rigors; diffuse myalgias; This is a spontaneous report from a contactable physician. This physician reported information for both mother and fetus/baby. This is a {enter maternal or fetus/baby} report.  A 31-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Batch/Lot number: EL9264) via intramuscular route, administered in right arm on 12Feb2021 11:15 as single dose for COVID-19 immunisation. Medical history included supraventricular tachycardia and polycystic ovaries from an unknown date and unknown if ongoing. She had known allergies to Sulfa (sulfonamide) and had reaction of urticaria. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMIN); fish oil; thioctic acid, ubidecarenone (COENZYME Q10 + ALIPOIC ACID); vitamin d [vitamin D NOS]; acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication, start and stop date were not reported. The patient previously took TDAD vaccine in left arm on 21Jan2021 for unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Batch/Lot number: EL3247) via intramuscular route, administered in right arm on 22Jan2021 11:45 AM as single dose for COVID-19 immunisation.  It was reported that there was no COVID prior vaccination and no COVID tested post vaccination. The patient experienced fever with chills/rigors, diffuse myalgias on 13Feb2021 02:00. The patient underwent lab tests and procedures which included body temperature: 100.8 Fahrenheit on 13Feb2021. She was 34 weeks pregnant at the administration of BNT162B2 vaccine (maternal exposure during pregnancy). The LMP date was given as 17Jun2020 and Due Date was given as 24Mar2021. She received acetaminophen as treatment. The seriousness of events was reported as non-serious. The outcome of Fever, chills/rigors,diffuse myalgias events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Severe body aches, chills, fever 101.0 headache for first 6-8 hours. Then profuse sweating
Patient's recieved Pfizer vaccine for first dose and Moderna vaccine for second dose. No notable adverse events reported from shelter.
Rec'd MENACTRA & GARDASIL #1 on 12/16/10 in afternoon. At approx 5:00 am next morning she awoke with dizziness, nausea, shaky, headache "slight" fever, (L) arm tender & "tingly" to fingers. Symptoms lasted 3 days, progressively better.
The following morning patient developed a rash on face & body. Went to ED. Was dx as allergic reaction and treated with steroid.
Patient received her vaccine at noon on 6/28/21. When she woke up in the morning on 6/29/21 she stated that her body had broken out in hives. The hives were noticed from the neck down to the pelvis. She said that the rash was not on the legs or arms and it was localized to the trunk of the body. She did not report trouble breathing and stated that the rash was just itchy.
Rash, itching, swelling, pain. All symptoms traveled down right arm from injection site in upper tricep and stopped mid-forearm. Injection given 2/6/04. Seen in ER on 2/9/04 8th shot. Reaction similar after 7th shot on 11/22/02.
on 01/09/2021 two days after receiving the 2nd dose of the vaccine my right thumb joints started to freeze and pop causing intense pain the next day 01/10/2021 my left thumb started to do the same. The date of my first dose was 12/18/2020  and the date of my 2nd dose of the vaccine was on 01/07/2012. I was hoping the pain, popping and freezing of my joints would go away and was temporary so I waited until 2/15/2021 to reach out to my provider. The pain persisted and I contacted my dr on February 15th when it was apparent this situation was not getting better but was getting worse. I had a tele-visit on February 16th. The provider ordered lab work and I had a follow-up visit after the results were released. She put me on tramadol, Levothyroxine and Vitamin D I have had several tele-visits with my provider she prescribed medication and then we added a steroid treatment to no avail. I will be contacting her on 3/15/2021 to discuss further treatment options and also let her know that my situation is getting worse not better and is spreading to other joints in my hands My thumb joints are totally freezing at this time and date 03/14/2021 I must force the joint to pop for them to move and this is extremely painful. The pain is now spreading to other joints in my hands and wrist. At this time and date the other joints are not freezing, but are causing me intense pain, the pain in my thumb joint are almost inbareable due to the forcing of the joints to pop to move.
Had a wheal raised 10 x 14 cm on the right upper arm, no fluctuance/no tender. Today was sent with hydroxyzine and hydrocortisone . Advised mother that if still worsening need to return to the clinic or ER. Warm compress. FU 3 days.
Approx 12 hrs after receiving vaccine dose number 2, I got severe chills, shaking, fever, and nausea. Now, 24 hrs after I still have body aches and a fever of 102.4
Several hours of extreme chills, which occurred within 6 hours of receiving shot, followed by fever for about 4 hours. Now, the following day, am experiencing weakness, tiredness, some muscle discomfort and off and on chills and overheating and some stomach pain.
Started with redness on her arm below the vaccine site; spread downward on arm; on 9/21/16 was 6x4.5 inch warm hard red swollen area.  Top border of area was approx 1 inch below vaccination site.  Treated with cephalexin.
This case was reported by a physician (also the subject) and described the occurrence of decreased therapeutic response in a 43-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). There were no concurrent medications. On unspecified dates (in the subject's early 30's) the subject completed 2 primary ENGERIX B series (unknown arm each administration) and at the time of reporting was still showing low titers. This is considered to be decreased therapeutic response. No additional details were reported.
Pt stated that approximately 1hr after administration, she experienced fever >100, extreme muscle pain, and swelling of upper left arm. Pt states she went to the ER around 2:00AM on 03/22/2017. Pt states she was given IV BENADRYL, and "anti-swelling" medication and was discharged afterwards.
There is a pattern after 2 month from each shot where the periods get irregular and painful; there is a pattern after 2 month from each shot where the periods get irregular and painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient received BNT162b2 (BNT162B2), on 21Apr2021 as dose 2, single (Lot number: ER8729) at the age of 28 years, in arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical Sie of injection: Arm, Batch/Lot number: Pfizer EN6207), administration date: 31Mar2021, when the patient was 28-year-old, for COVID-19 Immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset Jun2021, outcome "not recovered", described as "There is a pattern after 2 month from each shot where the periods get irregular and painful"; DYSMENORRHOEA (non-serious) with onset Jun2021, outcome "not recovered", described as "there is a pattern after 2 month from each shot where the periods get irregular and painful". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation irregular, dysmenorrhoea.  Additional Information: Third dose was administered on 22Oct2021, Anatomical site of injection: Arm, Lot number: Pfizer FE3592, fourth dose was administered on 19Oct2022, Anatomical site of injection: Arm, Lot number: Pfizer GJ2524. Prior vaccinations within 4 weeks: None and not on birth control and have not been since 2018. No hormonal medications since 2018. No prescribed medications. Started taking Flovitamins Jan2023 to help with period symptoms since shot has had no effect. In summer 2021, noticed periods were not on time. Periods became random by 2022. Didn't take much note as not in relationships at the time. In summer 2022, started tracking her cycle. Had gone from 4 week cycle to 45 days cycle skipping weeks at a time. Periods were long, painful and severe. Periods have never returned to normal with no birth control or medications being used since 2018, the only thing that's changed besides a flu shot in her is the C-19 shot. There is a pattern after 2 months from each shot where the periods get irregular + painful. They have not gone back to normal and we fear this will affect the ability to get pregnant with non-regular cycles.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201364680 same patient/drug, different dose;
Soreness; Mild swelling; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Soreness) and SWELLING (Mild swelling) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 025j20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced PAIN (Soreness) and SWELLING (Mild swelling). At the time of the report, PAIN (Soreness) and SWELLING (Mild swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Subacute Thyroidities leading to Hyperthyropdism Graves?s Disease, Thyroid eye disease
Hot to Touch Sensation - Near Injection Site; Swelling - Near Injection Site; Hardness - Near Injection Site; Itchy - Near Injection Site; Rash - Near Injection Site; Arm Pain - Near Injection Site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE INDURATION (Hardness - Near Injection Site), VACCINATION SITE PRURITUS (Itchy - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included CITALOPRAM for Antidepressant therapy, MELATONIN for Sleep disorder.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE INDURATION (Hardness - Near Injection Site), VACCINATION SITE PRURITUS (Itchy - Near Injection Site), VACCINATION SITE RASH (Rash - Near Injection Site) and VACCINATION SITE PAIN (Arm Pain - Near Injection Site). At the time of the report, VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE INDURATION (Hardness - Near Injection Site), VACCINATION SITE PRURITUS (Itchy - Near Injection Site), VACCINATION SITE RASH (Rash - Near Injection Site) and VACCINATION SITE PAIN (Arm Pain - Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant product included supplements for general health. Treatment included cold compress as advised by HCP to alleviate the symptoms.
In the evening after getting the vaccine there was redness, swelling, and intense itching. The redness and swelling has progressed down past the elbow, itching has subsided. Patient has used ice packs, and may consult with primary care provider for further treatment.
Within 30 minutes of recieving the H1N1 nasal vaccine I began feeling tightness in my throat.  It became difficult to talk in a deep breath and my throat started to feel sore.  Conditions worsened through the night and by morning I had developed a dry cough.  At 9:30 am I started having chills and by 12:00 I started running a temperature and my cough became productive.  At 12:00 noon my temperature was 102 degrees and Motrin was administered.  It is 9pm on October 29th, 2009 and symptoms have not lessened.
Headache, Myalgia, Arthralgia, Fever, fatigue and chills Narrative:
Janssen COVID-19 Vaccine EUA Uncontrollable Shakes, fever spiking between 100 and 104, throwing up, pounding headache, aches throughout body
After the shot within 24 hours I was tired had a head ache and my arm hurt   8 days after my shot my injection site was swollen and itchy. Day 9 swollen itchy red and hot.
4inchx4inch  red patch of skin, hot to touch, firm and painful at site of injection on  deltoid region of right arm.   States occurred 8 days following vaccine on February 12, 2021.  States remained for several days and then eventually started to fade and dissipate.
Blacked out completely while driving home on the highway about 50 minutes after the vaccine was administered with no reactions during the observed waiting period..  After awakening, nauseated, vomiting,  woozy, dizzy,  felt extremely cold, drained, somewhat unclear. Friend in vehicle was able to get to the steering wheel and we went off road into trees and grass on the side of the road several hundred feet until she was able to stop the vehicle. I did not come to until after the vehicle stopped. First responders came, reports made.  Examined and tests done at Emergency room.
Delayed vaccine reaction- rash started one week post first dose; a telehealth doctor gave me a 21 pill six-day steroid pack which held it at bay, an urgent care doctor then thought I had a fungal infection and gave me a topical cream but two days post the steroid pack I had a rash in multiple areas of my body and the second urgent care doctor I saw said I was having a delayed reaction to the vaccine.  He said since I wasn't having any breathing issues, my reaction was considered mild.
Whole body its itchy; got worse when she received the second dose and the booster dose; Itchy site of injection; itch gotten worse after getting the 2nd and booster doses; Scratch until skin is marked; This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH (Scratch until skin is marked), PRURITUS (Whole body its itchy), CONDITION AGGRAVATED (got worse when she received the second dose and the booster dose) and VACCINATION SITE PRURITUS (Itchy site of injection; itch gotten worse after getting the 2nd and booster doses) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced SCRATCH (Scratch until skin is marked). On 29-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy site of injection; itch gotten worse after getting the 2nd and booster doses). On an unknown date, the patient experienced PRURITUS (Whole body its itchy) and CONDITION AGGRAVATED (got worse when she received the second dose and the booster dose). At the time of the report, SCRATCH (Scratch until skin is marked) and VACCINATION SITE PRURITUS (Itchy site of injection; itch gotten worse after getting the 2nd and booster doses) outcome was unknown and PRURITUS (Whole body its itchy) and CONDITION AGGRAVATED (got worse when she received the second dose and the booster dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: positive Positive.         No Concomitant medications were reported.   This case was linked to MOD-2022-478698, MOD-2022-478879 (Patient Link).
Extreme vomiting, explosive diarrhea. Patient had diarrhea for over a month. Patient now has fructose intolerance and is extremely sensitive to many foods.
5 hours after the vaccine was given, chills started. My temp rose from 97.4 to 102.7 in the matter of 1 hour. Body aches, headache, chills, sweating. Had to take Tylenol.  I am 110lb. Is it possible that the dose given is too big?
Information was received from a health care professional on 30 October 2009 and 02 November 2009 which consisted of a cluster of 14 identified patients who experienced adverse events after receiving H1N1. This case represents one patient out of the cluster of 14 identified patients. A 16-year-old female patient had received an injection of H1N1 (route and site of administration not reported), lot number UP006AA on 30 October 2009, and one hour later she experienced dizziness and her eyes felt heavy. She also developed itching on both of her arms; however there was no visible sign of anything on her arms. Prior to vaccination her blood pressure was 118/76 mmHg, and after vaccination, her blood pressure was 94/62 mmHg. At the time of the report, her recovery status was unknown and no additional information was provided. The reporter for this case is the same as for case numbers 2009-04660, -04661, -04663, -04664, -04665, -04666, -04667, -04668, -04669, -04670, -04670, -04671, -04672 and -04673. Documents held by sender: None