chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 8th May 2018 12:30, the patient received the 1st dose of SHINGIRX (intramuscular) .5 ml. On 8th May 2018, less than a day after receiving SHINGRIX, the patient experienced injected limb mobility decreased, pain in arm, chills, fever and muscle pain. On 10th May 2018, the patient experienced upper back pain. The patient was treated with MEDROL. On an unknown date, the outcome of the injected limb mobility decreased and muscle pain were unknown and the outcome of the pain in arm, chills and fever were recovered/resolved and the outcome of the upper back pain was recovering/resolving. It was unknown if the reporter considered the injected limb mobility decreased, upper back pain and muscle pain to be related to SHINGRIX. The reporter considered the pain in arm, chills and fever to be related to SHINGRIX. Additional details were provided as follows: On the day of vaccination, in the evening, the patient's left arm began to ache badly. The patient then developed chills and fever that same evening that lasted two or three days. The ache in the patient arm continued to get worse to the point that she could hardly lift it. By Thursday, 10th May 2018, the patient's arm was still aching but she had developed severe pain in her upper back more on the left side. The patient went to her physician and he told her that he thought that it was muscular due to her trying to move her arm. The back pain did not resolve, the patient went to see an orthopedist on Monday, 14th May 2018. Orthopedist prescribed her a MEDROL dose pack and told to the patient if that did not work that she should start physical therapy. The MEDROL dose pack did not work so she started physical therapy on 21st May 2018.  The upper back pain was resolving.  The arm ache lasted for approximately five days.
Individual began feeling dizzy and reported feeling painful sensation in her neck within approximately 5 minutes after receiving the vaccine.  She was tachycardic in the 120s.  She was encouraged to take deep breaths, offered water, and given 50 mg Benadryl IM in the right deltoid. After several minutes post Benadryl administration, her symptoms resolved. She was taken home by a family member.
On 9.6.22, after returning on a flight, I became heavily congested. I awoke on 9.7.22 with a raging sore throat. Home COVID test was negative. Took an allergy pill (1x) at night thinking it was seasonal allergies. Awoke on 9.8.22 with sore throat, headache, and low grade temp. Another at-home COVID test returned a negative result. Had a antigen test at Pharmacy on 9.8.22 at around 4pm to make sure I was clear to attend a weekend wedding.  When results weren't returned, I visited my local doctor on Friday, 9.9.22 in the morning for covid and strep test as sore throat and low grade fever were on and off present. Developed into bed for 2 days with on and off temp (highest was 100.6), sore throat (resolved on 9.11.22), chills, headaches, and cough which began on 9.9.22.  Cough remains.
Horrible headache, stuttering, loss of speech within 12 hours of shot, pain and weakness down left side,  fever, chills, arm swollen and red and hot to touch, extreme fatigue, shaking.. Loss of taste and smell.  O2 levels dropped to 80s.  Symptoms still have not fully resolved, but speech has returned and O2 levels returned to normal. Still have horrible headache and arm is still swollen, red and hot to touch. Still have a fever.
Localized rash with no superficial Lesions "dewdrops on a rose petal" at site of injection.
Patient under the age of 60 presented to the clinic to receive COVID and RSV vaccine. Patient was 40 years old
This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 11Aug2021 (age at vaccination 21-years-old) as dose 2, single for covid-19 immunization. The historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date was not reported) via an unspecified route of administration, administered in arm left on 01Jul201 (age at vaccination 21-years-old) as dose 1, single for covid-19 immunization. Medical history included anxiety, depression and patient previously took Prednisone and experienced allergies. Concomitant medications included citalopram, omeprazole (PRILOSEC), bupropion (BUPROPION) taken within two weeks. Patient did not any other vaccine in four weeks. On 14Aug2021, patient stated that she has begun losing taste and her ability to smell, everything smelled like a chemical now. She is also extremely nauseous all day but especially after eating anything, sore arm, raised skin at injection site and low-grade fever. Patient has stated that she had not been diagnosed with COVID -19 prior to vaccination and not been tested since the vaccination. Patient received no treatment for the adverse events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2.
Problems with stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Problems with stomach) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (Problems with stomach). At the time of the report, ABDOMINAL DISCOMFORT (Problems with stomach) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Added patient age. Added event outcome updated.
Rash all over torso x3 days after getting vaccine. Smallpox vaccine, This is the immunization that I had a reaction to. Red spots on abdomin and arm.
Information has been received from a medical secretary concerning a 12 year old female patient with attention deficit disorder and an allergy to morphine who on 22-FEB-2007 was vaccinated IM in the left arm with her first dose of Gardasil, lot #656049/0187U. Concomitant therapy included amphetamine aspartate, amphetamine SO4/dex (ADDERRAL TABLETS), and fludrocortisone acetate (FLORINEF). On 26-APR-2007 the patient was vaccinated IM in the left arm with her second dose of Gardasil, lot #656049/0187U. The reporter mentioned that the patient developed dizziness, sleeplessness, and low blood pressure after receiving her second dose (date unspecified). She was seen in the office on 10-MAY-2007 for complaints of headaches and dizziness. Her blood pressure on that date was 120/60 lying, 110/60 sitting, and 100/60 standing. The patient called the office later that day with complaints of continued dizziness and was seen in the emergency room (she was not admitted to the hospital). On 11-JUN-2007 the patient called to report difficulty urinating. On 12-JUN-2007 she refilled prescription for fludrocortisone acetate (FLORINEF). On 13-JUN-2007 the patient complained of a rash, 3 episodes of hives, and that her "feet and hands feel very hot, but the mother stated they were cool to touch". On 19-JUN-2007 the patient was seen by a cardiologist. On 25-JUN-2007 she called to complain of trouble sleeping and was given a prescription for hydroxyzine. On 25-JUN-2007 she called to complain of trouble sleeping and was given a prescription for hydroxyzine. On 26-JUN-2007 she was seen by a neurologist. The notes stated that there was no findings from the exam. The neurologist stated possible inner ear disturbance. The patient was given mezlicine. The neurologist continued that the patient may have a questionable "demits" and chronic fatigue. The office notes also stated that the mother was concerned that these problems were from Gardasil and the neurologist did not believe so, but the mother was concerned that he dismissed this too fast. The patient's symptoms persisted. Additional information has been requested.
July 15-Got MMR shot. July 21-Started having headache on lower left back of head. July 24-Persistant headache is worse. July 25-Experiencing severe throbbing headache in same area. July 26-Felt very tired all day. July 27-Husband contacted the pharmacy that gave the shot and clinic that had required I take it. Felt tired with shoulder pains, developed rash on face/back, slept all day; woke with pain and swollen lump on back of left knee. July 28-pain and swollen on back of left knee still there; met with an EMT; advised to take anti-histamine and ibuprofen. Told to go to ER if joint swelling worsens. July 29 -Pain now in both knees, rash on chest, face, and back. EMT conducted  medical exam. Blood pressure was higher than normal. Temperature was slightly elevated. Confirmed reaction to MMR, advised to go to ER if lump gets worse.
Parent states she developed a rash on her chest and some temperature of about 101. She had some diarrhea that night and was not eating from that night through the next day. She had at least 9 episodes of diarrhea through the next day. The rash extended from the chest down to the upper legs. The diarrhea abated over next several days and gradually began to take more food.
Information has been received from a registered nurse (R.N.) concerning an approximately 76 year old female patient with no drug reactions or allergies and no pertinent medical history who on 30-SEP-2011, was vaccinated with a dose of ZOSTAVAX (Merck) SC (lot number 670820/0660AA, expiration date 04-AUG-2012). Concomitant therapy included MAXZIDE, metoprolol, sertraline HCl, vitamin D (unspecified), tramadol HCl, omeprazole, diltiazem HCL (manufacturer unknown), LIPITOR, alprazolam, aspirin, calcium (unspecified) and FLONASE. It was reported that on an unknown date, the patient developed shingles after receiving ZOSTAVAX (Merck). The patient also had "micro-hematuria". Prednisone, VALTREX and VICODIN were given as treatment for the adverse events. There was "urine test" performed which revealed "micro-hematuria". The patient sought medical attention, she saw the physician. At the time of the report, the patient's outcome was not recovered. Follow-up information has been received from a physician via herpes zoster questionary concerning the 76 year old female retired patient with no known drug allergies and no history of chickenpox or recent exposure to herpes zoster who on 30-SEP-2011, was vaccinated with a first dose of ZOSTAVAX (Merck) 0.65ml, in the site of the right deltoid (lot number 670820/0660AA) and with the third dose of FLUZONE (lot number 1725) in the left deltoid as a concomitant therapy. It was reported that on 13-MAY-2012, the patient developed "significant zoster outbreak", on the right side, T4 - multiple lesions. No other symptoms occurred. The patient rated the pain as 9 on a zero (least) to ten (most) scale. No rash occurred at the site of the injection or elsewhere within 42 days of the vaccination. Maximum temperature was 98 (date unspecified). There was no direct fluorescent antibody done and no specimen collected for PCR and a photo was not taken. It was reported that the patient did not seek medical attention (previously reported as "she saw physician"). At the time of the report, the patient's outcome was recovering from Zoster outbreak. The relationship between the events and ZOSTAVAX (Merck) was unknown. Additional information is not expected.
Stomach cramps; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received first dose received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported), via an unspecified route, administered in Left Arm, of administration on 15Mar2021 at 12:45 (age of 38-year-old at vaccination) as a 1st dose, single for COVID-19 immunization. The patient's medical history included Allergy: Allergic to medications, food, or other products (Allergy to any specific substance or product was not specified). Prior to vaccination the patient was not diagnosed with Covid-19. The patient's concomitant medications included vortioxetine hydrobromide (TRINTELLIX) and lisinopril within 2 weeks of Covid-19 vaccination. The patient was vaccinated at United Center facility. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021, the patient experienced stomach cramps, diarrhea. No treatment medication was received for the resulted events by patient. Since vaccination the patient was not tested for covid-19. The clinical outcome for the events stomach cramps, diarrhea was not recovered at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  DSU amendment (16Jun2021): Added Concomitant medication (TRINTELLIX), Vaccination facility (United Center), Suspect drug Lot number (Unknown to Not reported), Dose description (1st dose, single), Event onset (changed from 15Mar2021 to 16Mar2021), Clinical course and Case closure comment. Updated narrative accordingly.
patient could not eat ,drink or swallow medication, temp was 102F. Pt was weak, uncoordinated and could not walk. He was leaning over and had a change in mental status. 911 was called and patient went to the hospital by ambulance. He had chest xray, IV fluids and urine sample was collected.
Same arm,  rash and hives whole arm and top of hand. Mild onset 24 hrs after injection. Increased swelling, rash and itching at 48 hrs, spreading to hand.
Nose congestion; Soreness in shoulder at injection site; Fever/Chills; Inability to sleep the first night; Lingering headache (3 days); Backache (upper and lower); Sore neck; Nose bleed; Fever/Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: NASAL CONGESTION (non-serious) with onset Apr2021, outcome "unknown", described as "Nose congestion"; VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Soreness in shoulder at injection site"; CHILLS (non-serious), PYREXIA (non-serious) all with onset Apr2021, outcome "unknown" and all described as "Fever/Chills"; INSOMNIA (non-serious) with onset Apr2021, outcome "unknown", described as "Inability to sleep the first night"; HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "Lingering headache (3 days)"; BACK PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Backache (upper and lower)"; NECK PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Sore neck"; EPISTAXIS (non-serious) with onset Apr2021, outcome "unknown", described as "Nose bleed".  Additional information: Patient did not take any medications and was generally good health. It was mentioned that the patient tested positive for COVID post 2 doses of Covid vaccine and Comirnaty doses conclude on 25Apr2021.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
History of GERD, fussy, fever, diarrhea, blood in stool - MOC will observe child at home
Patient received Td shot and 15 minutes later he developed a systemic reaction with feeling warm, nausea and light headedness, like he was going to pass out. His blood pressure remained stable but his pulse elevated to 90 and then settled down again. The patient was asked to lie down and given some oral fluids and the episode resolved within ten minutes with no complications.
1st dose on 2020, never received the 2nd.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th September 2020 from batch number G4HX3 with expiry date 13th May 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comments: The pharmacist reported that the patient never received the second dose of Shingrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The VAERS details reported for the first dose of Shingrix. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case has been linked to the US2022AMR141306 case reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR141306:Same reporter
I received the vaccine on 01/13/2021. On 01/21/21, I noticed several hives on the anterior part of my neck along with itching of that area. On 01/22/21, the hives were gone upon waking, but returned that evening in the same spot, anterior portion of neck. I awoke on 01/23/21 and no hives were present. Later in the day I notice a flattened hive like rash by the injection site, on my upper shoulder, and the anterior part of my chest. This rash became more defined on the 01/24/21 and lasted through 01/26/21.
a lot of people are having heart problems after Covid vaccines; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (a lot of people are having heart problems after Covid vaccines) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (a lot of people are having heart problems after Covid vaccines). At the time of the report, CARDIAC DISORDER (a lot of people are having heart problems after Covid vaccines) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-403109 (Patient Link).
On 5/2/2021 I woke up with severe shortness of breath. I went to a walk in clinic two times and then I ended up going to the ER two times, and I have seen my primary doctor and a pulmonologist.  Through out all the visits they have done  lab work, chest x-ray, CT scan, Echocardiogram.  At the walk in they thought I had bronchitis so they prescribed an inhaler and another medication, later they prescribed a steroid, my first visit to the ER I was not prescribed nothing, the second time they prescribed oxygen at night and as needed, and from my pulmonologist they prescribed a different inhaled steroid.
Expanding warm red circular area around injection site on Left arm-covering much on upper arm. Patient came for an office visit 5 days later, rash on arm improved but with new bump and new rash on face.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 13-JUL-2015, the patient was vaccinated with improperly stored MMR II lot # J016232 and 19-DEC-2015 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
99.9°F Fever; Aches , joint pain , headaches; tenderness to touch; started to urinate frequently; sore arm; chills; A spontaneous report was received from a  consumer concerning an  68 -year old,  male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and    experienced  sore arm/ pain in extremity, chills, fever/ pyrexia, Aches , joint pain , headaches/ Pain, tenderness to touch/ tenderness, started to urinate frequently/ urine output,  The patient's medical history, was not provided by the reporter, included no known allergies,  Concomitant medications was  not reported.   On  13 Feb  2021prior to the onset of the symptoms, the patient received their First of two planned doses of mRNA-1273 (Batch number 013L20A)  for prophylaxis of COVID-19 infection.  On Unknown date after vaccination patient reported , the events sore arm, chills, fever, Aches , joint pain , headaches, tenderness to touch   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events, was not provided.  The outcome of the events  sore arm, chills, fever, Aches , joint pain , headaches, tenderness to touch, started to urinate frequently Unknown
SO YOU HAD FEVER, CHILLS AND BODY ACHES AND FATIGUE FOR A COUPLE OF DAYS
Received call from pts. family reporting  patient had a syncopal episode at home following vaccines and EMS had to be called.
16 YO the adult dosing of Engerix-B; 16 YO the adult dosing of Engerix-B; This non-serious case was reported by a physician via call center representative and described the occurrence of overdose in a 16-year-old male patient who received HBV (Engerix B adult) for prophylaxis.   On 14-AUG-2023, the patient received Engerix B adult. On 14-AUG-2023, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: 16 YO the adult dosing of Engerix-B) and inappropriate age at vaccine administration (Verbatim: 16 YO the adult dosing of Engerix-B). The outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 14-AUG-2023 On the day of reporting, the reporter had a situation where he/she gave a 16 year old the adult dosing of Engerix-B, which led to inappropriate age at vaccine administration and overdose. The reporter wondered if there was any recommendations on the wrong dosing from the manufacturer. The reporter will transfer over to Medical Information.
5 days late for her menstruation; breaking out; PMS syndromes; This is a spontaneous report from a contactable consumer. A 31-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), intramuscular (left arm) on 12Jan2021 14:00 at a single dose for covid-19 immunization. Medical history included celibate and on birth control. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in 17Dec2020 (first dose). It was reported by the patient that she is 5 days late for her menstruation. She is also experiencing PMS syndromes and have been breaking out after having the second dose of COVID-19 vaccine; all on 14Jan2021. The outcome of the event breaking out was recovering while not recovered for the other events.