chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt weird; Sore back that felt like organs inside sore, not like muscle ache; Awful night sweats; Awful chills 12 hours after vaccine; Swollen tender lymph node on axillary of injection side; Fever 101.4; Felt so sick; Swollen tender lymph node on axillary of injection side; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150), via an unspecified route of administration in the left arm on 12Apr2021 at 12:15 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included food allergy (garlic, onion).  The patient received unspecified birth control medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration in the left arm on 22Mar2021 at 12:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. The patient previously took amoxicillin (MANUFACTURER UNKNOWN), ceftriaxone (CEFTIN), vancomycin (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications and experienced drug allergy.   Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 00:00, the patient experienced awful chills 12 hours after vaccine, swollen tender lymph node on axillary of injection side, fever 101.4, next day, felt weird, sore back that felt like organs inside sore, not like muscle ache, awful night sweats then fever broke and the patient felt fine. The patient was barely able to function at work, the patient felt so sick. The patient went home and slept at 5pm until next morning. The patient was not tired and had no headache, slept from feeling awful. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 13Apr2021 at 00:00, the patient underwent lab test and procedure which included body temperature and result was shown as 101.4 (units unspecified). The clinical outcome of the events awful chills, swollen tender lymph node on axillary of injection side, fever 101.4, felt weird, sore back that felt like organs inside sore, awful night sweats and felt so sick were resolved on an unknown date in Apr2021.    No follow-up attempts are needed. No further information is expected.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient passed out for a few moments after feeling nausea, came to, felt a little tingling fingers, which resolved quickly. mild sweat on forehead, went away shortly.  Observed patient, with his mother here, for additional 20 minutes, felt well enough to leave on his own.
Heavy, early menstrual bleeding. Period started 10 full days early (very abnormal for me), and lasted 14 days (usually lasts 4 days), with a very heavy flow (bled through several tampons, when normally I dont even have to wear them during a typical period).
Patient explained that she had arm soreness and swelling within the first 24 hours of vaccination, by day 12 (Thursday 4/26/2018) her elbow was red and hurting and her hand was red, on day 14 (Saturday 4/28/2018) she went to urgent care where they diagnosed her with cellulitis and sent her to hospital, where patient was admitted for one overnight. Patient was discharged on Sunday 4/29/2018 and received generic AUGMENTIN 875 mg po BID for 7 days.
24 hours post vax, the pt experienced the sensation of a knot in her throat. 30 hours post vax the pt experienced pain in both great toes. 48 hours post vax, the pt developed redness, stiffness and swelling of the fingers on both hands. The redness, stiffness and swelling migrated from finger to finger. She was seen by her primary care physician. An arthritis panel and Lyme titer performed were negative. The physician prescribed a 5 week course of Vioxx. The sensation of a knot in the throat resolved one week after onset. The toe pain resolved one to two weeks after onset. The finger redness, stiffness and swelling resolved after an unspecified period of time.
reconstituted Shingrix with sterile water; reconstituted Shingrix with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-MAY-2022 Reporters comment: This case was reported for an unspecified number of patients.  Pharmacist reported that, one of their clinics might have reconstituted the Shingrix antigen powder reconstituted with sterile water.  An undetermined number of patients might have received this improperly reconstituted doses. The reporter consented to follow up. Additional supportive information: One of clinics might have reconstituted the Shingrix antigen powder reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case had been linked with case US2022058848, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022058848:Same reporter
8 days after the vaccine, I developed a mildly itchy rash at the injection site, that last a few days.
pt began crying inconsolably about 3hrs p/vax;pt cried for 4 1/2hrs during which mom called the peditricians office x 3;was not seen either in his office or in ER;
Administered VARIVAX 0.5 ml and PROQUAD 0.5 ml. Patient got a double dose notified mother of what happened and explained if fever became uncontrollable to take patient to ER and that patient would have leg pain.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 73-year-old male patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020) for prophylaxis. Concomitant products included doxycycline and SINGULAIR. On 5th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, several hours after receiving SHINGRIX, the patient experienced fever, erythema of extremities, pain in arm and swelling arm. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever, erythema of extremities, pain in arm and swelling arm were recovered/resolved. The reporter considered the fever, erythema of extremities, pain in arm and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The patient experienced fever (body temperature 99-100 degree F) which lasted for a week. The patient also experienced red, swollen, and painful reaction on arm that lasted for 2 weeks. The reaction started within a few hours after receiving the SHINGRIX. The patient called the pharmacy and the pharmacist recommended TYLENOL for the fever and pain.
Parent arrived with child on 10-31-17 to Health Department to seek medical attention for painful swelling in Right Deltoid muscle. Father stated that he first noticed the swelling on 10-12-2017, the day after the HPV was given in the deltoid muscle. He thought the swelling would go down, but two weeks later it continues to be swollen, so he went to doctor's office for treatment, but they sent him to the health department. Nurse examined L Deltoid, muscle was swollen, slightly warm. Child reported some pain with movement. Referred child back to a medical facility for treatment. Doctor's office care or if unable to obtain care there, instructed to go to Emergency room. Child uninsured.
Onset of projectile vomiting within 24 hours of  administration of Rotatec, requiring pyloric US. No bloody stools. Reports of blood tinged emesis.
Nose and lip swelling 11 hours after receiving FLUMIST- advised to take BENADRYL.
Very tiny red spot at injection site,warm to touch ,bump at site - started on the third day. Soreness at site started the next day. Uncertain if related but have a small bump on scalp right side itched like crazy started 3/31/21 on 4/1/21 noticed rt side base of head very sore area and can feel slightly enlarged gland also got very tired on 3/30/21 then 3/31/21 I was so tired that I had to take a nap slept 4 hours slept very deep and hard
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Medium, Additional Details: Patient says she had itching, headache, flushed, and tingling tongue
ANAPHYLAXIS; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This solicited report received from a consumer concerned a 17 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose,1 total, start therapy date were not reported for prophylactic vaccination (coded to inappropriate age at vaccine administration and Off label use). 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 anaphylaxis. Approximately 8.5 hours after vaccination, patient had developed blisters in mouth and itching all over body, patient took 25mg Benadryl at that time. Shortly after that patient had developed breathing problems (throat closing). Prior to arrival to ED (Emergency department) patient took epinephrine, dexamethasone, acrivastine and NS bolus IV. The patient improved and was sent home from ED (Emergency department) with prednisone 5 days. On an unspecified date the patient visited Emergency department. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from anaphylaxis, and the outcome of off label use and inappropriate age at vaccine administration was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and anaphylaxis as related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and inappropriate age at vaccine administration, and off label use. Company causality between covid-19 vaccine ad26.cov2.s, and anaphylaxis was related. Company causality between covid-19 vaccine ad26.cov2.s, and inappropriate age at vaccine administration, and off label use was not related. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220243496-COVID-19 VACCINE Ad26.COV2.S- Anaphylaxis. This event(s) is labeled per RSI and is therefore considered potentially related.
After 6 days, I got what felt like a mosquito bite around the injection site - small swelling and an itch. After several hours, the spot got larger and started itching more, and turned red. The next day the spot had gotten larger, itching and swelling stayed the same, and the redness comes and goes depending on heat. No pain in the area. It grew slightly on the 3rd day, maybe 1 inch high by 2 inches across total. Currently still moderately itchy, no soreness, and the swelling has definitely leveled off/subsided slightly.
Reaction started on July 31 - had some wheezing, tachycardia, temp 103.6, severe myalgia, difficulty sleeping due to agitation despite taking zolpidem (Ambien). This lasted throughout week. On 8/3/09 patient was seen by primary care provider who stated that there was hard red indurated area over left deltoid with some increase in redness of skin overall but noted that it did not look urticarial.  Also stated that reacion is resolving and patient is afebrile and not in respiratory distress so close follow-up is best approach.
Patient came into clinic with complaint of left arm twitching only where vaccine was given. Upon observation patient did have visible muscle twitching.
Symptoms of numbness to hands and feet, general weakness of hands and legs and was not able to open clothespin or climb stairs, loss of balance which started approximately 5-7 days following vaccine for Hep-B. Treatment with physical therapy. 60 day follow-up dated 9/22/00 provided no additional data.
like a vomiting in the back of her throat; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach) and  (like a vomiting in the back of her throat) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In August 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2020, the patient experienced ABDOMINAL DISCOMFORT (upset stomach). In February 2022, the patient experienced NAUSEA (like a vomiting in the back of her throat). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach) and NAUSEA (like a vomiting in the back of her throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  On an unspecified date in Feb-2022, the upset stomach was more like it would come back up, like a vomiting in the back of her throat.  No treatment information was provided.
The vaccine given was expired, patient was notified and monitored for any adverse reactions. Scheduled time to come back in so that they may start the series over again.
Severe chills and loss of bladder control. Nausea and vomiting for two weeks after shot. Muscles spasms so severe I thought my back was going to break.
Rashes on both of my arms and swollen feet. My left foot is the worse. Have seen a specialist who recommended me to contact.
persistent vesicular rash, which was diagnosed as herpes zoster or shingle; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   In 2013, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2014, the patient was treated in a clinic, for a persistent vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages.
DOSE ADMINISTERED AFTER BEING STORAGE FOR 30 DAYS BETWEEN 2-8 DEGREE C
Woke with TDAP vaccinated arm too sore to use for regular activities. By 3PM, severe thirst and medium grade headache. By 3:30PM, severe body aches, cramps in feet, and mild fever onset. By 5PM, nausea set in and had to rest. At 5PM took 500mg Tylenol. By 5:45PM headache and body aches lessened to allow for walking and standing. At 9:45PM chills, body aches, and queasy stomach. 11PM took 220mg naproxen sodium.  Sunday at 10:30AM queasy stomach, no body aches, but arm still to sore to lift. Sunday 1PM some soreness in arm, but other symptoms gone.
Feeling Chills and palpitations.  At first patient couldn't explain symptoms stated they come and go. Blood pressure was taken at 1745 on Left Arm 170/100 P 120, 160/80 P - 108, O2 @ 99%. After 15 minutes  BP came down  18:15 Blood pressure was 160/80 P - 94. O2 at 98% 18:25 Heart rate still elevated @ 111. EMS was called and arrived at 18:35. EMS asked Patient if she wanted to go to ER and stated no. EMS explained vital signs were level and didn't see she needed to go to the ER. They confirmed with her they would not transport her. Patient started to have a panic attack while sitting down in chair with family and EMS at her side. Patient was instructed to call PCP if not going to ER. Daughter confirmed she understood the instructions and patient was released.   EMS vitals 167/92 BS - 137 HR - 102 retook before leaving and got 136/96 HR - 99
Patient with significant right leg DVT requiring thrombolysis by vascular surgery. She will need to continue on anticoaggulants outpatient.
15 mins p/vax 20JUL94 pt devel a red rash on face, abdo & antecubital spaces of both arms; pt remained alert & pleasant; no dyspnea or other resp impairment noted;
This spontaneous report as received from a pharmacist refers to a 67 year old female patient. On 28-MAR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (dose not reported, subcutaneous route). Concomitant therapy was not reported. It was reported that a couple days later, approximately 30-MAR-2013, after the patient received the ZOSTAVAX, the patient experienced measles like rash on upper arm. The patient then had a follow-up appointment with an unspecified physician and was diagnosed with shingles. The patient then received an unspecified medication from her pharmacist and the symptoms resolved and the patient made a full recovery on an unspecified date. Additional information has been recovery.
Information has been received from a healthcare worker concerning a 7-year-old male with no pertinent medical history or allergies who on 02-OCT-2000 (also reported as 20-OCT-2000) was vaccinated in the arm with a 0.5 mL dose of Varivax (Lot #635452/0768K). Concomitant therapy included MMR II. There was no illness at the time of vaccination. On 09-JAN-2007 at 09:00, the patient experienced a generalized, scattered papular rash which was itchy for 4-5 days. Unspecified medical attention was sought. The patient was diagnosed with chicken pox. No diagnostic studies or lab tests were performed. On 16-JAN-2007 the patient recovered. No additional information was provided. There was no product quality complaint involved. Additional information is not expected.
Grand Mal Seizure 36 hrs post-vaccination.  No other vaccines were given at that time.
After the second Moderna vaccine, I have experienced numbness on my right side.  I was rushed to the ER thinking I was having a stroke. I had a MRI done on my brain, neck and back, seen a spinal surgeon, seen a neurologist and had an EEG and EKG test, and everything comes back fine.  I have also had a full physical and tried dry needling to help but nothing works. I would like to know if the vaccine is causing all of my numbness and if there is any cure.  It has been going on for 4 months now with no relief and no answers to what the cause is besides the vaccine.  I would like information sent to me on how to treat these side effects.  The doctor information I provided is the neurologist however I can also provide my general doctor, the ER doctor and others for confirmation of all the tests I?ve been through.
Severe dizziness and inability to stand without support, some confusion for the past few months, but slowly subsiding over time. All other causes ruled out by MD.
Body ache; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), PYREXIA (Fever) and FATIGUE (Fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 025A21A) for COVID-19 vaccination.     The patient's past medical history included Heart failure (Left Side Heart Failure) and Asthma. Concurrent medical conditions included Obesity.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body ache), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, MYALGIA (Body ache), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.            Action taken with mRNA-1273 in response to the drug was not applicable. No treatment information provided by the reporter and no concomitant medication was reported.   This case was linked to MOD-2021-138232 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient developed cellulitis at injection site. Patient subsequently was hypotensive/septic and had to be hospitalized.
pt recvd vax 25MAR95 & devel itchy, red area around inj site 26MAR95;
Patient was in the observation room following her first dose of the COVID-19 vaccine. Approximately 5 minutes after receiving the vaccine, patient's father was talking to RN, when Pt's eyes rolled back and she began experiencing a syncopal event. Pt was lowered to the floor, and her feet were elevated, and she quickly came to. She was assisted back into a chair to begin an assessment, when her eyes rolled back a second time. She was again moved to the floor and feet were elevated. Vitals were taken, BP was 98/55, Pulse - 78, O2 - 96% on room air. At this time patient was pale and eyes were dilated. Father was agreeable to calling EMS and pt was transported to Medical Center. She was already looking improved when leaving on a stretcher. She did not hit her head or otherwise hurt herself during these two syncopal events.
redness/rash around injection site - symptom first noticed on 03/05/21.  No pain or itching.
Information has been received from a physician concerning an infant patient who on an unspecified date was vaccinated with a dose of ROTATEQ. The physician reported that the infant vomited the dose of ROTATEQ. Additional information has been requested.
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female with no known drug allergies and no medical history who on 12-JAN-2009 was vaccinated with the first dose of GARDASIL (Lot# 661531/1311X), IM. There was no concomitant medication. The patient was subsequently determined to be pregnancy by an unspecified clinic. Her last menstrual period was 07-JAN-2009. The patient sought medical attention. There was no lab and diagnostic test performed. No problems were reported. The patient's estimated delivery date was 14-OCT-2009. Additional information has been requested.