chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came to the pharmacy after 5 days of administration because her arm was red and hot. It didn't itch or hurt.
Went in for Moderna booster.  Asked pharmacist if I was getting a half dose (.25).  She said no, that Moderna booster was to be full dose.  Paperwork said 0.5.  Went home and researched and dose should have been half.
pt recv vax & devel swelling-piercing high pitch cry-vomiting, anorexia, feb, inc sleeping pattern;
mouth was dry with foam in mouth; her hips were killing her; headache/slight headache; she had a fever; feet hurt/arm hurt; nausea; foamy mouth/foam in mouth; spine hurt; ribs hurt; her bones all hurt bad; esophagus dry; eyes swollen; eyes red; face swollen; weak; body felt weird; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (spine hurt), MUSCULOSKELETAL CHEST PAIN (ribs hurt), BONE PAIN (her bones all hurt bad), OESOPHAGEAL DISORDER (esophagus dry) and DRY MOUTH (mouth was dry with foam in mouth) in a 45-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 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced FEELING ABNORMAL (body felt weird). On 18-May-2021, the patient experienced SPINAL PAIN (spine hurt), MUSCULOSKELETAL CHEST PAIN (ribs hurt), BONE PAIN (her bones all hurt bad), OESOPHAGEAL DISORDER (esophagus dry), FOAMING AT MOUTH (foamy mouth/foam in mouth), EYE SWELLING (eyes swollen), OCULAR HYPERAEMIA (eyes red), SWELLING FACE (face swollen), ASTHENIA (weak), MYALGIA (feet hurt/arm hurt), NAUSEA (nausea) and PYREXIA (she had a fever). On 19-May-2021, the patient experienced DRY MOUTH (mouth was dry with foam in mouth), ARTHRALGIA (her hips were killing her) and HEADACHE (headache/slight headache). The patient was treated with LIDOCAINE (topical) on 18-May-2021 for Pain in foot, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) on 18-May-2021 at a dose of 1 dosage form. On 17-May-2021, FEELING ABNORMAL (body felt weird) had resolved. On 19-May-2021, EYE SWELLING (eyes swollen), OCULAR HYPERAEMIA (eyes red), SWELLING FACE (face swollen), ASTHENIA (weak), NAUSEA (nausea) and PYREXIA (she had a fever) had resolved. At the time of the report, SPINAL PAIN (spine hurt), MUSCULOSKELETAL CHEST PAIN (ribs hurt), BONE PAIN (her bones all hurt bad), OESOPHAGEAL DISORDER (esophagus dry), DRY MOUTH (mouth was dry with foam in mouth), FOAMING AT MOUTH (foamy mouth/foam in mouth), ARTHRALGIA (her hips were killing her), MYALGIA (feet hurt/arm hurt) and HEADACHE (headache/slight headache) outcome was unknown.            No concomitant medications were reported Action taken with mRNA-1273 in response to the event was not applicable.
Patient slid down in the chair, closed eyes, passed out.  Her hands clinched tightly, and she gently began to shake.  This lasted less than 1 minute.  Her eyes opened and she broke out into a sweat.  It took between 5-10 minutes for patient to recover.  She was able to leave on her own.
Arm Soreness - Near Injection Site; Arm Redness - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm Soreness - Near Injection Site) and VACCINATION SITE ERYTHEMA (Arm Redness - Near Injection Site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm Soreness - Near Injection Site) and VACCINATION SITE ERYTHEMA (Arm Redness - Near Injection Site). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 26-Jan-2021, VACCINATION SITE PAIN (Arm Soreness - Near Injection Site) and VACCINATION SITE ERYTHEMA (Arm Redness - Near Injection Site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication use information was unknown. Treatment information include ibuprofen and antihistamine.   Reporter did not allow further contact
Received Dtap 3 on 7/13/2004. Pt complained of swelling and tenderness to Right upper arm on 07/14/04 and taken to hospital ER at 9:00PM. Pt given 250mg Keflex QID PO x 10days. Pt returned to clinic 7/15/04 09:00AM with right upper arm swollen from deltoid muscle to 4 inches below muscle, reddened, and warm to touch, pt c/o tenderness.
Patient had chills, nauseated, headache, and swelling at the injection site. Patient went to an Express Care and was examine by a Doctor. Patient was sent home.
I have Crohn's Disease and i also had severe diarrhea due to my Crohn's
menstrual irregularities/she only had one period after receiving the vaccine; This is a spontaneous report from a contactable Pharmacist reported for herself. A 48-year-old non-pregnant female pharmacist received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 29Jan2021 (at the age of 47-year-old) as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historic vaccine included bnt162b2 in Jan2021 as dose 1, single for COVID-19 immunisation. She had her both doses of the vaccine last Jan2021, she was 47 years old when she got the vaccine and now, she's 48-years old. She got her 2nd dose on 29Jan2021. She's asking for additional information regarding the menstrual irregularities on an unknown date in 2021. She only had one period after receiving the vaccine - there's no hot flushes, she did pregnancy test 3x and the results were negative - she's not pregnant, and she stated that it's unusual for her to be late. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After patient received vaccine, patient (while still in chair) passed out. PT was out for more than 15 seconds. Patient woke up and was fine. Paramedics were called and they escorted her out of the store.
pt devel a painful rash described as shingles w/in 2 days of receiving flu vax;
warm to the touch IS; Itch IS; Redness IS; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm to the touch IS), INJECTION SITE PRURITUS (Itch IS) and INJECTION SITE ERYTHEMA (Redness IS) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced INJECTION SITE WARMTH (warm to the touch IS), INJECTION SITE PRURITUS (Itch IS) and INJECTION SITE ERYTHEMA (Redness IS). At the time of the report, INJECTION SITE WARMTH (warm to the touch IS), INJECTION SITE PRURITUS (Itch IS) and INJECTION SITE ERYTHEMA (Redness IS) outcome was unknown.            No concomitant and treatment drugs were reported.
Four days, post vax of MMR, the pt could not stand or walk. I attributed it to her having the croup but after 2 more days, she was not better. Her pediatrician sent us to a Neurologist who sent us to the hospital. She still has balance problems exacerbated by fatigue, illness or extreme changes in the weather. She trips and/or falls multiple times per day. Annual follow up states pt has not recovered.  Pt still has balance problems which are exacerbated by illness, fatigue, and large changes in outside temperature.
BUD date excursion, BUD was 4-7-23 and vaccine administered. 4-21-23.
Pt recv vax on 10/23/98; on 10/24/98 pt exp swelling at injection site w/ pain (2.5 x 1.5 cm).
PED VAC 5-11 USED FOR ADULT VAC (WAS NOT DILUTED)
Patient received a Diluent of the DTap/IPV and not the Hib of the Pentacel.; Initial information received on 16-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old female patient who was vaccinated with 0.5 ml diluent of the dtap/ipv and not the hib of the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] via intramuscular route in the left thigh on 13-Dec-2019. The lot number U6218AA, UJ015AAA and UJ015AAA and expiry date: 26-Oct-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  It was actual medication error due to inappropriate reconstitution technique.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Chills; aches; fluish; with a knot at the injection site; he felt burning in his injection arm; metallic taste in his mouth; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the second dose bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) on 13Apr2021 as single dose in arm for covid-19 immunization at the age of 59-year-old. The patient received the first dose bnt162b2 (Batch/Lot number was not reported) on 23Mar2021 as single dose administered in arm for covid-19 immunisation at the age of 59-year-old and experienced a little sore on injection arm in Mar2021 and a metallic taste in his mouth on 23Mar2021 with outcome of unknown. The patient medical history and concomitant medications were not reported. The patient felt burning in his injection arm about 10 minutes after injection on 13Apr2021. The patient woke up 14Apr2021 with a knot at the injection site and has been experiencing chills, aches, and feeling overall flu-ish. The patient also reported a metallic taste in his mouth when he got the vaccine on 13Apr2021. The outcome of events was unknown. No treatment information was reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Swelling, redness, pain in left arm within 24 hrs of injection. ER doctor reported swollen lymph nodes in axilla. Advised cool compresses & Tylenol & started child on Keflex. Still being treated.
Pentacel was given at the same time as Hib.  Pt. did not have any reactions.
Shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The reporter had a patient that experienced shingle should the patient  receive the 2nd dose of Shingrix. The reporter did not consent to follow-up. This was obtained via chat and visitor disconnected when the reporter asked for credentials.
Seven weeks after the first dose I began to feel unwell. One week later I had fallen down the night before. I felt like my legs were very weak. My wife noticed that I was hallucinating. We went to Urgent Care and my D Dimer was high as well as my blood pressure. I had a slight fever. I was hospitalized on 05/26/2021. I was diagnosed with Pneumonia,, Community Acquired  and ended up being hospitalized for 12 days. My blood pressure was hard to control and my hospitalization was extended. I had fluid in my Lungs. During the stay, I had bleeding in my stomach.  It has been eight weeks and I have lost 24 lbs and my Stomach is still upset. I am still receiving Home Health Care.
Left Deltoid/Upper arm red and warm to touch. Blistering with oozing.
Staring spell, lasting 1 hours. ER evaluation done. Temperature 102F.
pt recvd vax; myalgia, chest pain, dizziness, n, day  p/ vax; tx w/ advil; blood work, EKG nl;
Mild fever and body ache. Oddly, I had an intermittent feeling of something cold touching the inside of my right forearm, as if I had spilled cold water or brushed up against a cold piece of metal on clothing, but in fact no cold water or metal were present; it was a phantom sensation. I had never experienced such a thing before. All symptoms subsided in a little over 24 hours without treatment.
Patient described having pain in addition to the injection site. The pain radiated to her armpit. She also had pain and stiffness with her right shoulder. She said had extreme pain in trying to raise her arm above her shoulder. There was also 2 red streaks that started about 3 inches from the injection site, (towards to and going into the armpit). The streaks started a couple of inches down and towards the abdomen from the injection site. The pain started that evening. Two days later she came to the pharmacy to show me the reaction. She stated the redness has gone down but is still present. The lesions are still red and raised.
3 rd Moderno vaccine given in left on at Health clinic -All seem fine until October 31 when I had a breakout of shingles on the right side of my neck went to see my internal medicine Doctor Who diagnosed and gave me anti-virus  medicine and also gabapentin for pain Just wanted to inform you that I did get shingles and I don?t know if anybody else who has taken the vaccine has had the same outcome I am fine now today is December 24, 2021
2 cold sores the next day after vaccine. usually get cold sores but haven't gotten one in over a year. treating with acyclovir
Moderna 2/12/21, 3/12/21, 11/5/21. Positive on 10/13/22
Information has been received from a physician in the form of medical record concerning a white female patient who on 18-MAR-2008 was vaccinated with the first dose of PEDVAXHIB, on 15-MAY-2008 was vaccinated with the second dose of PEDVAXHIB and on 22-JUL-2008 was vaccinated with the third dose of PEDVAXHIB.  Secondary suspect therapy included HEPATITIS B VIRUS vaccine rHBsAg (yeast) (manufacturer unknown).  Concomitant therapy included POLIOVAX and PNEUMOCOCCAL vaccine (unspecified).  On 25-JUN-2008 the patient experienced mild thrush.  The physician advised to hold on treatment for a few days and see if it resolved on its own since it was a very mild case.  Also use some water after bottle to rinse and if she failed to improve or she worsened start the NYSTATIN ORAL suspension after feeding 1 ml 4 times a day, paint on and use until clear.  Subsequently, the patient experienced very mild papular rash over the entire perineum both labia down through the buttock and cheeks.  No pustules, no vesicles.  Diaper rash may indeed of fungal nature in that it was redder.  The patient's mom had been using NYSTATIN and it seems to be fading.  However, the patient was teething and acidic urine might be responsible for symptoms as well.  The patient would use very thin layer of cream sparingly once a day and might continue with the rest of the NYSTATIN.  On an unspecified date, the patient's skin there was fairly symmetrical clusters of 2-3 mm mildly erythematous, popular lesions on posterior aspect of both thighs just inferior to the diaper line.  Several of the lesions appeared umbilicated although not all of them did.  Rash, bilateral posterior thighs was most similar to molluscum but that it could be another form of viral rash.  This type of rash could linger for several weeks.  At the time of reporting, the outcome was unknown.  This is one of several reports received from the same source.  Additional information has been requested.
Within minutes of vaccine, dizziness, rest of the day dizziness and tingling all over body, day two body aches, day three to present, extreme upper arm pain/muscle weakness at site of tetanus injection (upper rt arm).
I had a strong immune response, "flu-like symptoms. Fever, chills, skin aching, exhaustion, loss of appetite, fatigue since the evening of the second shot. Had no problems with the first dose
PT reports chills since 1700 after receiving JJ vaccine at 0945. reports taking 1000mg tylenol 1800.
Had the vaccine on Monday morning 3/1/21, today (3/3/21) was woken up at 1am with severe nausea.. vomiting and diarhea; Had the vaccine on Monday morning 3/1/21, today (3/3/21) was woken up at 1am with severe nausea.. vomiting and diarhea; Had the vaccine on Monday morning 3/1/21, today (3/3/21) was woken up at 1am with severe nausea.. vomiting and diarhea; Had the vaccine on Monday morning 3/1/21, today (3/3/21) was woken up at 1am with severe nausea.. vomiting and diarhea. Also have a slight headache and sluggish; Had the vaccine on Monday morning 3/1/21, today (3/3/21) was woken up at 1am with severe nausea.. vomiting and diarhea. Also have a slight headache and sluggish; This is a spontaneous report from a contactable other healthcare professional. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Mar2021 at 10:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient's medical history were reported as none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. On 03Mar2021 at 01:00, the patient woke up with severe nausea, vomiting, diarrhoea, slight headache and was sluggish. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe nausea, vomiting, diarrhoea, slight headache and sluggish were recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Swelling, erythema and induration at local injection site ((L) lateral thigh). Sx control with BENADRYL liq soln, OTC TYLENOL/ADVIL for inflammation/pain control, and ice pack x 15 mins BID-QID.
2-shot vaccine and shingles/suspected vaccination failure; have Very bad shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 56-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The patient (reporter's aunt) currently have had very bad shingles and both of them had the updated 2 shot vaccine. The reporter stated that but it was still a good idea to get the vaccine, as it apparently did work for most people, just not for everyone. The case was linked with case US2022AMR125486, reported by same reporter for different patient. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR125486:Same reporter
LEFT EYE AND EYE BALL HURTS; LEFT EYE LID HURTS TO BLINK; EYE LID CRAMPS; HEADACHE ACCOMPANIED WITH DISCOMFORT WITH LIGHT (COULD NOT LOOK AT THE LIGHT); HEADACHE MIGRATES FROM ONE SIDE TO ANOTHER AND TO TOP OF HEAD; PAIN IN LEFT SHOULDER ON SITE OF THE VACCINE FOR WHOLE MONTH AND LONGER; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included asthma, and concurrent conditions included border line diabetic, breast cancer, and eye lid cramps. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced pain in left shoulder on site of the vaccine for whole month and longer. On 03-APR-2021, the subject experienced headache migrates from one side to another and to top of head. On 06-MAY-2021, the subject experienced left eye and eye ball hurts. On 06-MAY-2021, the subject experienced left eye lid hurts to blink. On 06-MAY-2021, the subject experienced eye lid cramps. On 06-MAY-2021, the subject experienced headache accompanied with discomfort with light (could not look at the light). Treatment medications (dates unspecified) included: paracetamol, menthol/methyl salicylate, and acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in left shoulder on site of the vaccine for whole month and longer, and had not recovered from headache migrates from one side to another and to top of head, left eye and eye ball hurts, headache accompanied with discomfort with light (could not look at the light), eye lid cramps, and left eye lid hurts to blink. This report was non-serious.
Headache Narrative: States worst headache, "debilitating." States took ADA and s/s resolved, but returned that evening around 1800. Took ASA, Tylenol, and a muscle relaxer; again symptoms resolved. States she awoke this morning with headache which was again relieved with OTC meds. 1/19 Headache gone; now beginning with cold s/s rhinorrhea, sinus pressure.
Large, inch-high by about 3-inch wide swelling and very painful at injection site; joint pain, fever, and fatigue to the extent that normal activity was impossible and going to bed was required. Felt much better after bed rest and limited activity for about 24 hours. Arm/injection site stayed very sore for about 5 days.