chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PAIN ALL OVER BODY; BONE PAIN/COULD FEEL EACH ONE OF BONES BECAUSE THEY WERE HURTING SO BAD; COLD SWEAT; FEVER THAT WOULD NOT GO DOWN; EXTREME HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. 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 pain all over body, bone pain/could feel each one of bones because they were hurting so bad, cold sweat, fever that would not go down, and extreme headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever that would not go down, and the outcome of pain all over body, cold sweat, bone pain/could feel each one of bones because they were hurting so bad and extreme headache was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Had shots 05/13/05- went to ER 05/15/05 @ 11:42PM with c/o temperature of 100.3 F , fussy, and crying for 2 days. At ER, stated - immunizations on 05/13 and ss began on 05/14/2005. DC home S/s probably due to immunizations. Saw MD on 05/16/05 in office and pt doing well then.
Cellulitis; Itchy; Hot to the touch around the injection site; Left arm swelling; A hard lump; 4"x3" big red area; Pain in center of injection site; Lower lip got numb; This spontaneous case was reported by a nurse and describes the occurrence of CELLULITIS (Cellulitis) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension since an unknown date, GERD and Bowel dysfunction. Concomitant products included FISH OIL for Cholesterol, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) from an unknown date to 20-May-2021 for GERD, LISINOPRIL for Hypertension, VITAMIN D3 for Vitamin D deficiency, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and VITAMIN E NOS for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (Lower lip got numb). On 15-Jan-2021, the patient experienced PRURITUS (Itchy), VACCINATION SITE WARMTH (Hot to the touch around the injection site), PERIPHERAL SWELLING (Left arm swelling), VACCINATION SITE MASS (A hard lump), VACCINATION SITE ERYTHEMA (4"x3" big red area) and VACCINATION SITE PAIN (Pain in center of injection site). On an unknown date, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Feb-2021, CELLULITIS (Cellulitis), PRURITUS (Itchy), VACCINATION SITE WARMTH (Hot to the touch around the injection site), PERIPHERAL SWELLING (Left arm swelling), VACCINATION SITE MASS (A hard lump), VACCINATION SITE ERYTHEMA (4"x3" big red area) and VACCINATION SITE PAIN (Pain in center of injection site) had resolved. At the time of the report, HYPOAESTHESIA ORAL (Lower lip got numb) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included 7- day course of antibiotics.  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.   This case was linked to MODERNATX, INC.-MOD-2021-079616 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Patient details, medical history, dosing details and 2 events added.; 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. MODERNATX, INC.-MOD-2021-079616:Second dose
Pt c/o hives / rash on arms, legs, torso and feet approximately 2 days after receiving vaccine. Treated with oral steroids and resolved.
Itching; Redness at injection site; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Soreness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Soreness). At the time of the report, VACCINATION SITE PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Reporter did not allow further contact
About 7 hrs after the vaccination I've experienced the side effect of tense pain on neck, lower back, thighs, calves and got more intense with time throughout the night and in the morning, daytime (now 12:34pm).  Hard to sleep, kept waking up at night.  I took Advil and Tylenol and couldn't tell if one was helpful then the other.  The pain was still there but not as intense.
First reports nausea within minutes of Covid vaccination. Then reported "warm, tingling" sensation and repeatedly stated "I don't feel good".  Her left arm at site of vaccine also became red and swollen.  Swelling of left face noted. Also reported feeling of panic.  Epi Pen was administered at the health department. EMS transport to ER where she received IV with Benadryl, Haldol and Zofran.   She was discharged from the hospital after several hours.
low grade fever 100-101 w/chills;aching & soreness all over;severe h/a 2 days p/vax;n/v 2 days p/inj;reported jaundice on 5JUN97 lasting 24hr;
fever 102.8, swelling, redness on area; relieved w/APAP;
DEATH.  Narrative:  Patient died after receiving COVID vaccine dose #1. 07/18/20: admitted to hospital for weakness/lightheadedness causing legs to give out and fall backwards, resulting in hematoma 12/15/20: seen by PCP, stable 02/03 seen in ID clinic for HIV follow up, nothing out of the ordinary 03/02 COVID vaccine dose #1 03/14 Pt died Cause of death unknown and undocumented at this time. Patient did not have an ADR immediately after vaccine or hospitalized before or after vaccine. Last hospitalization was July 2020 due to fall and associated hematoma. Death not likely due to vaccine, but due to comorbidities, including active HIV infection with detectable viral load. No known previous COVID infection.
Asthma  is causing me to use breathing treatments and inhalers  Breathing has become worse and am feeling tired and weak.  I feel like I have more mucous. I having coughing spells at  times.   I have started taking mucinex and Alegra D.   Will probably see  my doctor soon.
The patient woke up to severe itching at night; Rash developed on the posterior side of the entire legs, around knees (front side as well), elbows and the entire insteps; This is a spontaneous report from a contactable consumer or other non hcp.  A 51-years-old non pregnant female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: ew0017), via an unspecified route of administration, administered in Arm Left on 25Jun2021 14:15 (at the age of 51-year-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 previously took BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: ew0181), via an unspecified route of administration, administered in Arm Left on 04Jun2021 11:15 (at the age of 51-year-old) as dose 1, single for covid-19 immunisation. On 28Jun2021, the patient experienced the patient woke up to severe itching at night, rash developed on the posterior side of the entire legs, around knees (front side as well), elbows and the entire insteps. No treatment was taken as a result of events. The events were considered as non serious. The outcome of the events were not recovered.  Follow-up attempts are possible. Further information is expected.
On Tuesday, October 2 I received a flu vaccine shot at Clinic. I experienced unusual itching in my left foot Thursday afternoon and evening. Friday night I was afflicted with intense burning and itching in my left foot with shooting pain, similar to, but worse than the reaction I've had with Oxycodone and Tramadol following hospital surgery. My usual trick of immersing my foot in ice water helped but did not provide relief. The pain was bad enough that I asked my wife to pack a hospital bag in case I needed the ED. Toward morning, I tried TYLENOL and did get some relief. Saturday I used ice water, diversion and TYLENOL to make it through the day and was able to sleep a few hours several times during the night, resorting to ice water and TYLENOL as required. The condition improved further Sunday, with only one ice water/TYLENOL intervention during the night required. Monday forward I was ok. One lingering result is an increase in neuropathy in my left foot. I've had numb tips of the toes of both feet for some time on Amiodarone, but my left foot feels oddly more numb than before, not so much on the skin surface, but tissue inside the front half of my foot feels numb. I like to think this condition is slowly improving, but time will tell. I resolved to report this reaction, after a conversation with Dr (Psychology) in which she described a similar but less severe reaction she experienced following vaccination, except that it was located in a shin/ankle area.
symptoms after 1st vaccine - one day after nausea and second shot - three days of fever chills, on third day severe stomach pain where she could not stand up
Fever 100 deg, headache, extreme body ache, extreme lethargy, nausea, racing heart from this second of 2 series of Shingles immunizations 4 months apart.  Advil every 4 hours helped fever that began 15 hours after shot, and ended 60 hours later.  Severe headache remaining after other symptoms ended.
On 1/25/2021 I became itchy and trouble breathing and broke out in a red bumpy rash all over my body within 10 mins.  Went to ER and was given 60 mg steroid and 50mg Benadryl  the a Methylpresnisone taper back 4mg for 6 days plus Benadryl PRN and inhaler.
pt became lethargic, pale, limp, & listless, poor feeding for several hrs;
Information has been received from a pharmacist referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. On unknown dates the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # M033086 with expiration date 06-MAY-2018, lot # M027552 with expiration date 04-FEB-2018, dose and route were unknown). No adverse effects were reported. Additional information has been requested.
she was very dizzy; the room was spinning for 2 hours; headaches for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches for 2 days), DIZZINESS (she was very dizzy) and VERTIGO (the room was spinning for 2 hours) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included LEVOTHYROXINE, LISINOPRIL, ATORVASTATIN, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM 600 MG WITH VITAMIN D), DOCUSATE SODIUM, LORATADINE, VITAMIN D3, Vitamin C, MULTIVITAMIN [VITAMINS NOS], MAGNESIUM, ACETYLSALICYLIC ACID (BABY ASPIRIN), FISH OIL and ESTROGEN NOS for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced HEADACHE (headaches for 2 days). On 14-Feb-2021, the patient experienced DIZZINESS (she was very dizzy) and VERTIGO (the room was spinning for 2 hours). On 13-Feb-2021, HEADACHE (headaches for 2 days) had resolved. On 14-Feb-2021, DIZZINESS (she was very dizzy) and VERTIGO (the room was spinning for 2 hours) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment was provided.
Redness; Soreness; Swollen; Warm; This case was reported by a consumer via sales rep and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema, pain, swelling and skin warm. On an unknown date, the outcome of the erythema, pain, swelling and skin warm were unknown.   It was unknown if the reporter considered the erythema, pain, swelling and skin warm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient after the 2nd shingle shot had redness, soreness, about 2" in diameter swollen and a little warm. The patient asked is that pretty normal for second one the first one had nothing. The patient was concern about the events occurred after vaccination.
Initial and follow-up information has been received for the Merck Pregnancy Registry from a nurse and a certified nurse midwife concerning a 26 year old female who on 12-DEC-2006 was vaccinated with a first dose of Gardasil (Lot # 654389/0961F). On 07-FEB-2007, the patient vaccinated with a second dose of Gardasil (Lot #653736/0014U). Subsequently the patient became pregnant. The estimated date of conception was 02-JUN-2007. On 07-JUN-2007 the patient was vaccinated IM with a third dose of Gardasil (Lot #657737/0522U). Concomitant therapy included Percocet. Unspecified medical attention was sought. All "prenatal labs" were normal. The date of the patient's last menstrual period was 18-MAY-2007. The estimated date of delivery was 22-FEB-2008. On 23-JUL-2007 the patient underwent an ultrasound for viability which revealed missed abortion. On 24-JUL-2007, the patient underwent a uterine dilation and curettage. Other medications used during this pregnancy included prenatal vitamins. Upon internal review, the missed abortion was considered to be an other important medical event. Additional information has been requested.
Severe site pain, Severe stomach cramps, body aches (after 6 hours), vagovasal response, diarrhea, chills, fever, sweating (after 28 hours) Moderna COVID-19 Vaccine EUA
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ROTATEQ, oral (dose, lot # not reported) that was improperly stored. No adverse effects were reported. Additional information has been requested.
Menstrual cycle began unexpectedly 48 hours after receiving the 2nd Pfizer shot. It was not due for another 2 weeks. I had just had it April 15-19. My cycles are very regular so this did not make sense for it to start so soon. It is now 5/3, so I have been bleeding for 5 days now.
Information has been received from a physician concerning an adult who was vaccinated with hep b vaccine recombinant. It was reported that the pt experienced an upper respiratory infection. Additional info has been requested.
Tested positive 5/14/2021 showing very minimal symptoms, patient is pregnant with C section scheduled for 5/19/2021. At time of reporting patient is currently in OR so no birth weight yet.
Chills; Headache; bodyaches; feels a migraine coming again; Caller is not feeling too good; she wants something to relieve her pain and aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 83 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PAIN (non-serious), outcome "unknown", described as "bodyaches"; MIGRAINE (non-serious), outcome "unknown", described as "feels a migraine coming again"; MALAISE (non-serious), outcome "unknown", described as "Caller is not feeling too good"; PAIN (non-serious), outcome "unknown", described as "she wants something to relieve her pain and aches".  Additional information: Caller is not feeling too good. She is calling to ask what she should do for her symptoms after she got the Pfizer Covid19 vaccine. She reported she now has chills, headache, body aches, and feels a migraine coming again. She has never had migraines this bad. Caller mentions she received the vaccine last Friday. Caller wants to know what she can take to relieve side effects she is having from the vaccine? States this is the reason she called because she can not do anything. She is afraid to get the second shot because of these effects. she wants something to relieve her pain and aches. Caller asks does she need to get the second shot after having these effects?   No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Blood clot in each lung, chest pain, labored breathing, leg pain and upper back pain.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  An 82-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "htn" (ongoing). Concomitant medication(s) included: SIMVASTATIN; HYDROCHLOROTHIAZIDE; LABETOL; IRBESARTAN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: It was reported that the patient received other vaccine in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Pt had difficulty putting on his pajamas, he complained of pain in his Rt shoulder where the shots were given. Mother reports administering ibuprofen several times but pt had difficulty sleeping. No fevers and no previous hx of reaction to sensation.
My son developed a post-vaccination rash 31 days after receiving his second VZV vaccine (catch-up booster given at age 8).  Rash was a red, maculopapular rash, mildly puritic, over his chest, back, arms and legs, sparing his face and palms and soles.  He was otherwise asymptomatic, without fever, URI symptoms or any other signs of illness.  His rash is still present.
Case number PHEH2014US003829, is an initial spontaneous report from a pharmacist received on 21 FEB 2014. This report refers to a 15-year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX 2013/2014 (batch number: 006031A, expiry date: June 2014) at a dose of 0.5 ml intramuscularly on 05 JAN 2014. It was reported that he did not experience any adverse reactions since the maladministration (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population.
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included METFORMIN for Type 2 diabetes mellitus, PRAVASTATIN and HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HYDROCHLOROTHIAZIDE) for an unknown indication.   On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash) had not resolved.            Patient stated they have stopped taking their daily medicine due to the rash.
Doses administered between 12-24 hours post puncture; many people received a dose from a vial that was left at room temperature,; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered between 12-24 hours post puncture) and PRODUCT STORAGE ERROR (many people received a dose from a vial that was left at room temperature,) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered between 12-24 hours post puncture) and PRODUCT STORAGE ERROR (many people received a dose from a vial that was left at room temperature,). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered between 12-24 hours post puncture) and PRODUCT STORAGE ERROR (many people received a dose from a vial that was left at room temperature,) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided No treatment medications provided   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Non-Significant Follow up received on 23-nov-2021 and reporters email id and fax number updated