chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle pain so bad she was not able to walk properly or use her arms.; muscle pain so bad she was not able to walk properly or use her arms.; muscle pain so bad she was not able to walk properly or use her arms.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization.  The following information was reported: MYALGIA (non-serious), GAIT DISTURBANCE (non-serious), LIMB DISCOMFORT (non-serious), outcome "unknown" and all described as "muscle pain so bad she was not able to walk properly or use her arms.". Additional information: During the call she mentioned that after the third shot she had muscle pain so bad she was not able to walk properly or use her arms. She never had heart issues before, now if she made a deep breath, it was painful.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This initial non-serious spontaneous case was received a pharmacist on 20-Oct-2017, concerning an elderly female patient of unspecified age (reported as in 40's). On an unspecified date in 2015, the patient received influenza vaccine (dose, route of administration, anatomical location, batch number:173906 (as reported), expiry date, trade name, manufacturer: not reported). On the same day (within 24 hours), after vaccination, the patient had reactions such as flushing and non-specific skin symptoms. It was reported that the patient had recovered from the events within 24 hours.
Recurrent tinnitus, ringing in the ears, which worsened about 2-3 days after second shot and made me question whether to get the second dose; Severe headache 30 hours after first dose, then sporadically especially if fatigued, need to rule out whether they are migraines which I have never been diagnosed with before, continued and worsened after second dose. Malaise;  Night sweat about 36 hours after first dose;  Chills all night one night after the second dose. Soreness at injection site for first 30 hours after first dose, not as much after second dose.  Fatigue, depression and irritability in the weeks after the first dose. After the second dose it is too soon to tell.
Initial pregnancy report received from a healthcare professional on 03 April 2013. A 32-year-old pregnant female patient whose medical history was reported as "not applicable and concomitant medications were not reported, had received an intramuscular first dose of ADACEL batch number U4431AA (Anatomical site of administration was not reported0 on 02 April 2013. The patient's last menstrual period date was reported as 02 August 2012 and the expected date of delivery is 09 May 2013. The patient did not experience any adverse event. Documents held by the sender: None.
1335 - Pt arrived to observation feeling dizzy and not well. MD called, no answer. BP 210/109    1336 pt reported chest pain and 911 called.    1345 - care transferred to 911 and transferred to ED.
rash; Initial information received on 28-Aug-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Sales Representative).  This case is linked to case 2023SA265313.  This case involves a patient of an unknown age and gender who experienced rash after receiving vaccines Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid [BOOSTRIX] and Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspects Meningococcal A-C-Y-W135 (T Conj) Vaccine solution for injection and Boostrix (formulation: unknown) not produced by Sanofi Pasteur both with unknown strength, expiry date and lot number via unknown route in unknown administration site for immunization.  On an unknown date, the patient developed rash (unknown latency).  Information on the batch number was requested.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event.
Onset was during the night while sleeping.  Pt awoke with inability to move, spouse was able to move him and after a few hours mobility and feeling returned.  Pt was taken to local ER and cause/source was determined.
This spontaneous report was received from a Registered Nurse referring to a 20 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 16-FEB-2018, the patient was vaccinated with one pediatric dose of VAQTA injection 25/0.5, lot # N019924, expiration date on 02-SEP-2018, for prophylaxis (route of administration was not reported); instead of the recommended adult dose. No adverse effects were reported.
DOSE ADMINISTERED AFTER 30 DAYS STORAGE BETWEEN 2-8 DEGREE C
Had some itching on my stomach and my back; I saw some hives after a shower; This is a spontaneous report from a contactable consumer (patient). A patient of an unknown age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 12Jan2021 as a single dose, for COVID-19 immunization, lot number: EL3302. Medical history and concomitant medications were not reported. Patient received the Pfizer COVID-19 vaccine on 12Jan2021 and after like 24 hours he/she had some itching on stomach and back that kind of lasted for about 2 and half to 3 days, patient saw some hives after a shower, 24 hours later but other than that, no rash, no anything, the hives went away with diphenhydramine hydrochloride (BENADRYL) (Intent: Treatment). Patient still has itching and the day before the report (reported as yesterday) and the day of the report (reported as today) it is back to where it was like when patient first had it like stomach and back is insanely itchy so patient does not know and he/ she has not changed any laundry detergent, soap like anything in patient's life is different other than that vaccine, patient had no itching or anything of that nature before vaccine. Patient knows that the people in his/her office that also got Pfizer COVID-19 Vaccine down at same time also had a few days of same symptoms of itching, there is went away, so patient is trying to figure out if this is related because patient is due for second one in a week from today. Patient had not recovered from itching and recovered on unknown date from hives.
SkinRash, UrticariaPruritus, recurrent swelling and itching on day 2, day 7 and day 11 Narrative: patient called her pcp-on day 7 was told to use Benadryl and cold pack-improved, swelleing redness and itching recurred again on day 11  and was placed on oral steroids by pcp and advised not to take the 2nd dose
Patient developed a rash on chest after taking Oral Typhoid Vaccine.  Patient was given Oral Typhoid Vaccine On 10/28/2008 but did not take first dose until 11/16/08.  Reaction occurred about 24 hours after taking vaccine.
Mutism, no eye contact, GI distress every night unable to sleep, weight loss, constipation and first then chronic diarrhea, food aversions, social anxiety, ear infections, rotovirus, hand foot and mouth disease, chronic strep infections hyperactive, hand biting, head banging.
Ten  minutes after receiving his vaccination, he developed lightheadedness, vision changes (? vision became cloudy?) , paresthesias in bilateral upper extremities.  He was able to sit back down. No falls or trauma to his head or any part of his body. He was placed on a stretcher to a private section of the arena and monitored. Initially, his blood pressure was 103/69,  and interval blood pressure 20 minutes later was 139/73.  He was given water to drink, which he tolerated.  He reports that he has similar reactions to needles in the past, but the current presentation is longer than usual (symptoms usually resolve in five minutes). He was able to recover from the symptoms after 25 minutes of monitoring.
CAN'T LIFT SHOULDERS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 not reported, batch number: Unk) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. 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 APR-2021, the subject experienced can't lift shoulders. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of can't lift shoulders was not reported. This report was non-serious.
Chills beginning at night.  Woke up with headache, fever, chills, muscle aches, joint aches.  First full day was the worse with fever as high as 102.8.  Second day, low grade fever most of the day, chills.
While sitting upright I became dizzy.  I was assisted to my bed room and remained dizzy throught.  While laying down I was dizzy.  I took some tylenol pm and went to sleep.  When awakening, I was not dizzy.  Occasionally on day two and three, I feel like its going to start again but it has not.
Fever; Nausea; Lack of appetite; Muscle ache; Arm pain; Swollen lymph nodes; Headache; Malaise; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included doxycycline for prophylaxis.   Concurrent medical conditions included acne.   On 28th July 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient started doxycycline at an unknown dose and frequency. In July 2022, less than a week after receiving Shingrix, the patient experienced fever, nausea, appetite absent, muscle pain, pain in arm, swollen lymph nodes, headache and malaise. The action taken with doxycycline was unknown. On an unknown date, the outcome of the fever, nausea, appetite absent, muscle pain, pain in arm, swollen lymph nodes, headache and malaise were not recovered/not resolved.   It was unknown if the reporter considered the fever, nausea, appetite absent, muscle pain, pain in arm, swollen lymph nodes, headache and malaise to be related to Shingrix.     Additional Information: GSK receipt date: 29-Jul-2022 Reporter comment: This case was self-reported by the patient. The patient received Shingrix and experienced headache, swollen lymph nodes, mylasis, arm pain, muscle ache, lack of appetite, nausea, and fever. The patient referred to healthcare professional. The reporter consented to follow up.
Chills; sore muscles; Headache; Bloating; Constipation; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: ER8736) via an unspecified route of administration in the left arm on 25Apr2021 at 10:00 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25Apr2021 at 22:00, the patient experienced chills, sore muscles, headache and bloating/constipation. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event chills, sore muscles, headache and bloating/constipation was resolving at this time of this report.   No follow-up attempts are possible. No further information is expected.
Information has been received from a consumer concerning her a year old son who was vaccinated with a dose of PEDVAXHIB (name and manufacturer unspecified). The mother was trying to space out vaccines for her son to avoid serious reactions however after getting the vaccine the patient developed a fever. This is one of several reports from the same source. No further information is available.
light side effects from the first two doses.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (light side effects from the first two doses.) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VACCINATION COMPLICATION (light side effects from the first two doses.). At the time of the report, VACCINATION COMPLICATION (light side effects from the first two doses.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is on concomitant medication, but did not specify which ones. No treatment medication reported   This case was linked to MOD-2021-419522, MOD-2021-419562 (Patient Link).
First started with full body aches and shakes, temperature went up and heart rate remains resting at around 95 beats per minute before vaccine it was 60 bpm, feeling lightheaded and dizzy with an upset stomach.
The next morning I began to have a fever and extreme body aches. Later that day as these all increased, I began vomiting. My injection site did not hurt. By day 2, the injection site was very hot and red with  a large welt. This persisted and began to increase in size until it reached my elbow.  It took Tylenol pm at night to help with the histamine reaction. The initial symptoms resolved after day 3 but the arm swelling continued for a full week. It gradually decreased and then finally resolved on day 5.
first dose of shingrix in May 2022 and has not received a second shingrix dose since then; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in May 2022 in left arm).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first dose of shingrix in May 2022 and has not received a second shingrix dose since then). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-JUL-2023 The reporter had not received a second Shingrix dose yet. The reporter was unable to provide lot number or expiration date of the Shingrix dose she received. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Dizziness; Drop in heart rate; Extreme tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the arm left on 12Apr2021 at 12:15(at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included shingles, eczema and blood pressure high. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) and chlortalidone (CHLORTHALIDONE); all from unknown dates for unspecified indication. The patient previously received sulfa (unspecified) on unknown date for unknown indication. 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 07:00, the patient experienced dizziness, drop in heart rate and extreme tiredness. The clinical outcome of the event dizziness, drop in heart rate, extreme tiredness was recovered on an unknown date.  No follow-up attempts are needed. No further information is expected.
I developed Tinnitus around 8 AM on 3/23/21 in both ears.  I was driving my car around 10 AM and had severe Hypercusis and Headache.  I also had Photosensitivity.  Everything resolved by 3/25/21 except for Tinnitus.
Information has been received from a physician concerning a 2 month old male who on 30-JAN-2007 was vaccinated PO with a 2 cc dose of Rotateq. On 15-FEB-2007 the patient experienced bloody mucusy stool and went to the ER. He was tested for rotavirus antigens and was negative. The patient had stool cultures that were also negative. The patient was not admitted to the hospital. He went to a specialist and had a sonogram done which revealed a thickened bowel wall. After visiting the specialist the patient "was better". On 26-FEB-2007 the baby cried all day and the physician was worried about intussusception. It was also noted that the AE improved after stopping therapy. Upon internal review, bloody stool was considered an other important medical event. Additional information has been requested.
Information has been received regarding a case in litigation from a lawyer, an elderly female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 19-JAN-2015, at age 64, the patient was administered the ZOSTAVAX vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, and economic losses. Additional information has been requested.
sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 20-JUN-2023 This case was reported by patient via interactive digital media. The patient got the Shingles shots and had nothing more than a sore arm. Follow up was not possible, as no contact details were available.
1st Pfizer Vaccine, Lot#E0172. They put her on a cot for 30 minutes due to dizziness, anxiety and slight shortness of breath. Elevated legs and she started to feel better.
Patient experienced the side effects around dinner time, got the vaccine at 3Pm. Body aches, weakness, back pain, neck pain and shoulder pain that lasted for 2 weeks, also some depression and suicidal thoughts.
September 15/16, 2022, woke up to intense sharp pains in upper abdominal/lower chest area, radiating around both sides of my body to my back. Pain was 8 or 9 out of 10. After an hour, I vomited and the pain subsided to a 6 or 7. Pain lasted through September 26, 2022, and started to move only to right side (front and back). Seemed to be worsened by eating, so I stopped eating much. Dark urine and clay colored stools for a few days. Blood tests indicated elevated liver function and bilirubin. Currently completing ultrasound for suspected gall bladder or liver issues. I was 36 weeks pregnant at time of vaccination. Pregnancy history was healthy and normal. Delivery was July 21, 2022, normal baby. Birth weight 7lbs 13oz.
rash, malaise, syncope; The follow up received on 11/12/03 states onset of rash same day; treated in office 11/5/03 with Zantac/Solucottep. 11/4/03 returned to office with syncopy, hypotensive-to hospital ICU-remains in hospital 11/11/03.
Initial report received from a healthcare professional on 10 DECEMBER 2014. This case is linked to 2014SA172324 and 2014SA172330. A patient (age and gender not reported), whose medical history and concomitant medication were not reported, had received intramuscularly a dose of FLUZONE QIV, (batch number: UI245AB), (dose of vaccination not reported) in deltoid from 24-NOV-2014 to 10-DEC-2014. On an unspecified date, patient experienced rash on the opposite arm with redness and ringing in the ars. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as unknown. The patient required ER visit. Documents held by sender: none. Follow-up information received from a nurse on 07 APRIL 2015. A patient had received a dose of FLUZONE QIV on 10 DECEMBER 2014. On DECMEBER 2014, 20-30 minute after vaccination patient had experienced rash on the opposite arm with redness and ringing in ears. The patient did not received any vaccine within 4 weeks prior to vaccination. The patient had no known drug allergies (NKDA) and illness at time of vaccination. It was reported that, patient did not required emergency room visit. Patient did not had any laboratory investigations. Corrective treatment was reported as BENADRYL for reaction. The patient had recovered from all events on an unspecified date. List of documents held by sender: none.
This case was reported by a consumer via call center representative and described the occurrence of cramp in a 70-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose refer case: US2018GSK153743). On 14th August 2018, the patient received the 2nd dose of SHINGRIX. On 14th August 2018, less than a day after receiving SHINGRIX, the patient experienced cramp and diarrhea. On 15th August 2018, the patient experienced influenza, chills, fever and general body pain. On an unknown date, the outcome of the cramp, chills, diarrhea and general body pain were recovered/resolved and the outcome of the influenza and fever were not recovered/not resolved.  It was unknown if the reporter considered the cramp, influenza, chills, fever, diarrhea and general body pain to be related to SHINGRIX. Additional information was reported as follows: On 14th August 2018, Tuesday night before 6 pm, the patient was vaccinated with the 2nd dose of SHINGRIX. On the same evening of the vaccination, later the patient experienced diarrhea and feeling crampy. One day after the vaccination and a day before the date of reporting the patient felt achy all over, chills and was running a fever. Last night before the date of reporting, the fever was 3.3 degrees higher than the normal body temperature. The patient felt like he had flu. The patient did not feel as bad as the day before reporting, but still till the date of reporting he was running a low grade fever.