chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tries to speak and can''t get words out; speech is getting worse; Tremors; jerking and shaking everywhere she goes; having problems remembering things; she can't think most times; she is afraid to even try and cook because she did one day and she almost set her house on fire; The caller explains she is progressively getting worse.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: APHASIA (non-serious), outcome "not recovered", described as "tries to speak and can''t get words out; speech is getting worse"; TREMOR (non-serious), outcome "not recovered", described as "Tremors; jerking and shaking everywhere she goes"; AMNESIA (non-serious), outcome "not recovered", described as "having problems remembering things"; COGNITIVE DISORDER (non-serious), outcome "not recovered", described as "she can't think most times"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "not recovered", described as "she is afraid to even try and cook because she did one day and she almost set her house on fire"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "The caller explains she is progressively getting worse.". The events "tries to speak and can''t get words out; speech is getting worse", "tremors; jerking and shaking everywhere she goes", "having problems remembering things", "she can't think most times", "she is afraid to even try and cook because she did one day and she almost set her house on fire" and "the caller explains she is progressively getting worse." were evaluated at the physician office visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
LOCALIZED REACTION ON (R)UPPER DELTOID AREA PATIENT DENIES ANY DEVER, NO MALAISE; REPORTS SORE ITCHING THAN PAIN.  REDNESS MEASURES APPRX. 4.5 INCHES, CIRCUMFERENCE PATIETN REPORTS INCREASE IN REDNESS AND SWELLING (1WK)
This spontaneous case reported by a consumer, describes the occurrence of burning sensation (burning up), dyspnea (she can't breathe), hyperhidrosis (sweating), pain (her body hurts) and headache (her head hurts) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 035C21A and 035C21A) for COVID-19 immunization. No medical history reported. On Oct 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Nov 4, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 4, 2021, patient experienced burning sensation (burning up), dyspnea (she can't breathe), hyperhidrosis (sweating), pain (her body hurts) and headache (her head hurts). At the time of the report, burning sensation (burning up), dyspnea (she can't breathe), hyperhidrosis (sweating), pain (her body hurts) and headache  (her head hurts) outcome: unknown. Concomitant medications and treatment information not reported. On the Nov 4, 2021, she got her second dose with lot number 035C21A. 6 hours later, she felt like she had COVID-19 all over. She experienced: burning up, she can't breathe, sweating, her body hurts and her head hurts. This case linked to MOD-2021-377556 (patient link).
Pain in arm- paleness - nausea - fatigue approximately 22 hrs after vaccines & lasted for 24 hours.
Information has been received from a physician concerning a patient who was vaccinated with a dose of GARDASIL on an unspecified date. Subsequently the patient fainted before the needle was removed from the patient. The reporter felt that fainting before needle removed was not related to therapy with GARDASIL. Follow-up information has been received from a medical assistant concerning a 15 year old female who on 22-JUL-2009 was vaccinated with the third dose of GARDASIL (lot# 661531/1311X). There was no reaction reported after the first two doses of GARDASIL. Concomitant vaccination on the same day included a dose of VARIVAX (MSD, lot# and dose not reported). It was reported that after removing the needle, she talked to the patient for a while and then the patient reported feeling sick, and fainted on 22-JUL-2009. The patient was shaking and she wet herself a little. The doctor came in the room, they waited for a while then administered the VARIVAX (MSD). The medical assistant also reported that the patient's parent did not call back so she assumed that the patient was okay. This is an amended report. VARIVAX was changed from "secondary suspect" therapy to "concomitant" therapy since the AE occurred prior to VARIVAX (MSD) administration. Additional information has been requested. This is one of several reports from the same source.
Starting the 2nd day after administration, patient developed rash on her abdomen and back that lasted for 4 days. She took Benadryl OTC.
With varicella vaccine given 1/24/2011 and the one 2/25/2011 the client's arm where injection was given had a swollen, red, slightly heated area of 2x2 for several days.  This time the client had a headache to begin right after the immunization and continues today. Advised her to see pmd about h/a, none seen for this incident.
serious case gout; lethargic; still has tingling in buttocks; This case was reported by a nurse via sales rep and described the occurrence of gout in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number y442t, expiry date 10th July 2023) for prophylaxis.   On 24th June 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced gout (serious criteria other: serious as per reporter), lethargy and tingling. On an unknown date, the outcome of the gout and lethargy were unknown and the outcome of the tingling was not recovered/not resolved.   It was unknown if the reporter considered the gout, lethargy and tingling to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-Jul-2022 Reporter's Comments: The patient received 2nd dose of Shingrix on Friday, 24th June 2022  and had severe reaction, she was lethargic, had serious case gout and was still having tingling in buttocks at the time of reporting. The reporter consented to follow up.
24 hours of receipt  my eyes hurt. My bones and joints hurt. I was extremely cold.  Lasted approximately 4 hours 50 hours after receipt  my eyes hurt again. I was freezing and shaking.   My bones hurt again.I would start sweating and become extremely hot then cold again. My mouth was dry and I was extremely thirsty. I could not sleep.  This lasted approximately 6 hours and I was fine. All reactions were very similar to those experienced when I had COVID in December 2020.
Headache  Body aches  Nausea  Chills Fever 100.9 Fatigue
Information has been received from a consumer concerning her 5 year old son with no drug allergies who on 11-JAN-2005 was vaccinated with a 0.5 ml dose of MMR (lot number not reported). Suspect vaccination included hepatitis B virus vaccine (manufacturer unknown). Concomitant vaccination on the same day included poliovirus and DTaP. After the vaccination, in February 2005, the patient developed a severe lower intestinal reaction. In July 2006 he was diagnosed as lactose intolerant and was put on gluten free diet. After that, in July 2006 the patient's intestinal issues cleared up. Since then he had also been diagnosed with autism. Unspecified medical attention was sought. No laboratory diagnostics studies were performed. The patient had recovered from lactose intolerant in July 2006. Upon internal review, autism was determined to be other important medical events. Additional information has been requested.
2nd Pfizer vaccine on 27Mar, and on 29Mar woke up with rash and hives on both legs the entire legs.; 2nd Pfizer vaccine on 27Mar, and on 29Mar woke up with rash and hives on both legs the entire legs.; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer reporter for a male patient of unknown age who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 27Mar2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. On 29Mar2021, two days after vaccination the patient woke up with rash and hives on both legs the entire legs. The event outcome was unknown.  No follow-up attempts were needed. Information about lot/batch number could not be obtained.
TESTED + FOR COVID 2-22-22 ; DECEASED 3-5-22
Severe pain in right shoulder & some pain in left shoulder + neck area for past year, 2 Carbizone shots, Vioxx, Bextra
1610 Got light headed and sweaty.  Put feet up on chair and then took ee down to floor.  Sat with back against wall.  1/2 bottle of water and 3 juices.  Felt better after fluids 1615 BP 140/96 1620 HR 82 SPO2 100 on Room-air 1622 HR 85 SPO2 96% 143/98 1626 HR 79 SPO2 96 1632 HR 78 SPO2 97% 150/91 1638 HR 85 SPO2 97% States feels "ok" "not back to normal" 1640 HR 78 SPO2 96% 148/95 1642 Up in Chair 1646 HR 75 SPO2 95 140/91 1647 Walk to bathroom gait steady 1651 More water HR 86 SPO2 96% 133/93 Ready to go home 1657 Taken to car husband drove home.
Patient began experiencing a fever at 12 noon the following day. Patient was advised to treat fever with TYLENOL.
cried for a 3hr period & then cried mostly nonstop for about 3 days
Rash. From initial information received on 24/Oct/2003 from the patient's parent, who is a physician, regarding an adverse event occurring in the USA, it was reported that the four month old female patient received her second dose of DAPTACEL (lot number, route and site of admin. not reported) on an unspecified date. 24 hours post-immunization, the patient developed a fine rash on her legs and back. There was no redness at the site of injection. The patient's recovery status was not reported.
Fever of 99 degrees two hours after vaccines given. Hotness in the head area. From Day 2 until August 29, 2015, had smelly diarrhea and vomiting after every single feeding; increased crying, fussiness; general malaise; struggling to swallow during feedings; sleeplessness at night.
pt recvd vax 23FEB93 & 7MAR93 pt devel an erythematous macular rash which started on face & spread to include trunk, upper arms, & upper thighs; felt feverish on 9MAR93;
No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 6-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-JUL-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W020540, expiration date: 28-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
This spontaneous report as received from a health care worker refers to a 24 year old patient (gender unspecified). On 09-JUN-2014 the patient was vaccinated with ZOSTAVAX 0.5 ml, subcutaneous, anatomical location unspecified (lot number and expiration date not reported). No adverse effect reported. Additional information has been requested.
Experienced sensation of cold and shivering around 8:30 PM on the day of vaccination (April 10).  Went to bed at about 9:30 PM and fell asleep. Woke up around 11:40 PM and threw up. Ran fever of 102.2 F. To lower fever, took "nimesulida" (Spanish), kept ice bag on head and sprayed alcohol on feet.  Fever lowered around 1:00 AM. Slept the rest of the night. Felt tired and with a slight headache, similar to that of a sinus infection, coming and going throughout the next day (April 11), so stayed in bed. Symptoms were gone by the night. No more symptoms starting on April 12 and after that date.
My father suffered a heart attack due to blood clots clogging the artery to his heart.  He coded and was resuscitated  and had four stents installed after the blockage was cleared.   He had a second heart attack several days later when the stents clogged and had to be cleared.   He was hospitalized for several days for each heart attack.
Patient received injection 1/11/2021 and noticed a rash on the evening of 1/12/2021 around the injection site.  Rash spread down his arm, trunk, hip and thigh.  He took Benadryl without relief.  Patient presented to ED on 1/14/2021.  Given dexamethasone and methylprednisolone.  Discharged as hives were resolving.
Day after second vaccine, slight headache, stomach ache, did not last.  Next day sharps intermittent pains in hands, legs, abdomen, came and went then stopped.  Four days after second vaccine, very dizzy, extreme lethargy, chills.  The dizziness has subsided to being off balance and trouble focusing .   Still feel chills that come and go.  No fever when taking temp.  Was supposed to get my menstrual cycle two days after the second vaccine on May 8th and still have not gotten it.
chills; fatigue; headache; arm pain; body aches; Fever; This is a spontaneous report from a contactable nurse(patient). A 29-year-old female patient received the first dose of BNT162B2 (Lot number: EL0140), via intramuscular, in arm left, on 22Dec2020 18:15 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included Covid 19, pneumonia, anxiety/depression. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. No allergies to medications, food, or other products. No other vaccines were received within 4 weeks prior to the COVID vaccine. The other medication that the patient received within 2 weeks of vaccination was MULTIVITAMIN, sertraline hydrochloride(ZOLOFT), VITAMIN D3, ZINC, VITAMIN C. The patient experienced fever, chills, arm pain, body aches, headache, fatigue on 23Dec2020 09:00 AM. No treatment was received for the events. The outcome of the events was not recovered.
Pt became sweaty, itchy throat, Dr. assessment and recommendation to give pt 25mg of liquid Benadryl.
Vaccine given 5/13/02. Saw pt 5/21/02 for c/o pain at site with no redness or swelling. 5/24/02 pt called office stating pain L upper arm not improved. Can't lift L arm above head. C/O tingling in L fingers. MRI and pain med Tyl #3 ordered. 5/31/02 pain top L shoulder. Tenderness noted. MRI showed cellulitis. Antibiotic pt to see MD for EMG and NCS. 9/4/02 spoke to pt husband. 9/9/02 pt here for follow-up. Still has pain in L upper deltoid.
Red, warm to the touch, raised area at injection site. Recommended benadryl, ice, and watchful wiating
Left sided stiff neck Enlarged lypmh node on left side of neck above clavicle- tender to the touch Enlarged lypmh node under left armpit Redness and swelling at injection site Itching of injection site  Itching of eyes and body
Right thigh red, hot, swollen size of grapefruit. Omnicef.
DECREASED ARTHRITIS PAIN; This spontaneous report received from a health care professional via a company representative concerned multiple patients. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced decreased arthritis pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of decreased arthritis pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210740986.
1st dose Feb2020, 2nd not yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAV (Havrix) for prophylaxis.   Previously administered products included havrix (received 1st dose in February 2020).   On an unknown date, the patient did not receive the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose Feb2020, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-Mar-2023 Pharmacist reported that a male patient received a dose of Havrix and the 2nd dose had not been administered at the time of reporting. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Havrix, which led to incomplete course of vaccination.
received 1 ml of the vaccine; This case was reported by a consumer via call center representative and described the occurrence of overdose in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number T7S73, expiry date 17th September 2022) for prophylaxis.   On 24th September 2021, the patient received the 1st dose of Shingrix (intramuscular) 1 ml. On 24th September 2021, unknown after receiving Shingrix, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.  Additional details were provided as follows: The case was reported by the patient. The patient received first dose in left arm. The patient stated that he received 1 ml of the vaccine, which led to overdose. The reporter did not consent to follow-up. The case has been linked to US2021247338, reported by the same reporter, for a same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021247338:Same patient, different dose
hearing loss; Tinnitus in left ear/Crackling sound and ringing in ear; dullness; This is a spontaneous report from a contactable consumer (reporting for herself). A 33-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204, expiration date: unknown), via an unspecified route of administration in left arm on 05Mar2021 at 14:00 as SINGLE DOSE for COVID-19 immunization. The patient's medical history included Crohn's Disease, anxiety, and penicillin allergy. Concomitant medication included amitriptyline and celecoxib (CELEXA), both for unspecified indication. On 07Mar2021, the patient experienced tinnitus in left ear, crackling sound and ringing in ear, dullness and some hearing loss. The outcome of the events was not recovered.
Arm aches; Earache; Been in bed drinking fluids; Stomach Cramps; Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm aches), EAR PAIN (Earache), BEDRIDDEN (Been in bed drinking fluids), ABDOMINAL PAIN UPPER (Stomach Cramps) and HEADACHE (Headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm aches), EAR PAIN (Earache), BEDRIDDEN (Been in bed drinking fluids), ABDOMINAL PAIN UPPER (Stomach Cramps), HEADACHE (Headache) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Arm aches), EAR PAIN (Earache), BEDRIDDEN (Been in bed drinking fluids), ABDOMINAL PAIN UPPER (Stomach Cramps), HEADACHE (Headache) and MYALGIA (Body aches) outcome was unknown.            Concomitant medications include blood pressure medications.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.  Patient gave consent for safety to Follow-up.
approx 20 mins p/vax given pt became inconsolable w/a high-pitched cry; pt was inconsolable until 9PM when fell asleep; pt was cranky through the noc & for next 3 days; pt was back to nl routine;
right arm pain; tremendous pain that went down to her elbow; shingles; can't walk; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 23Mar2021 12:00 (Batch/Lot Number: EP7534) at the age of 62 years as single dose for covid-19 immunisation. Medical history included fibromyalgia on the left side from a previous stroke, diagnosed about 5 years ago, stroke diagnosed 8 year ago and pulmonary hypertension from 03Oct2007. Patient had no family medical history relevant to AE. Historical vaccine included a shingles shot 8 to 10 years ago and it didn't protect her from the shingles this time. Unknown lot, NDC, and expiration date for the shingles vaccine. Patient had no concomitant medications. Patient had no additional vaccines administered on same date of the Pfizer Suspect, had no previous immunization with the Pfizer vaccine considered as suspect. Patient reported shingles post first dose and confirmed shingles outbreak started post second vaccination. Patient experienced first shot: right arm pain. The first shot the patient got in the right arm and it was still killing her when she went to get the second dose. Patient right arm had tremendous pain that went down to her elbow and woke her up because that was how bad it was. The pain the patient's arm happened the day of the first shot day or a couple of days later, she can't remember. The shingles pain was so bad she had been in bed and can't walk. Patient had no relevant tests. Outcome of events were not recovered.  No follow-up attempts are needed. No further information is expected.
Pt presented to clinic on video (12/21/2020) almost two weeks after flu administration with concerns of continued left arm pain after vaccination, pain with movement, and inability to use arm/lift objects due to pain. Pt states pain started immediately after receiving vaccine and the she "has never felt pain so bad" after a vaccine. She has received flu shots and other vaccines without issues. She states that arm pain significantly worsened for 2 days and was "extreme" and then improved slightly but has plateaued in improvement and now pain is moderate for the last almost 2 weeks. It is not painful to touch or swollen or red, but patient is unable to perform ADLs due to arm pain, unable to lift objects, and has pain with movement/use of arm. She is right hand dominant. Pt advised to take ibuprofen 600mg every 8 hours, ice the area for 20 minutes 3-4 times per day, and allow the arm to rest (limit use) and to not lift any objects heavier than 5lbs. Referral placed to orthopedics for possible SIRVA. Pt to f/u in one week or sooner if sx worsen or fail to improve.