chrisvoncsefalvay/vaers-outcomes huggingface dataset:
GENERALISED ACHING; SORE ARM; JOINTS HURTING; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) 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 generalised aching, sore arm, joints hurting, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.4 F. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/guaifenesin/paracetamol/phenylephrine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from generalised aching, joints hurting, and fever, and was recovering from sore arm. This report was non-serious.
This spontaneous report as received from a pharmacist refers to a 60 year old female patient. On 17-JUL-2017, the patient was vaccinated with ZOSTAVAX, subcutaneous for prophylaxis. On 18-JUL-2017, 2 days after onset of therapy, the patient experienced injection site erythema, injection site induration, injection site warmth and injection site swelling. The outcome of injection site erythema, injection site induration, injection site warmth and injection site swelling was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
After getting the 2nd dose of the Pfizer vaccine I had a difficult time breathing and I was also very sleepy. After the 15 minutes I left. When I went home, I was still very tired, my whole body felt cramped and strained. That day at around 11pm I started to feel very cold. No matter what I put on my body would not heat up. Then after a while I got a fever which cause my whole body to heat up. It felt like there was fire inside. At around 3 o'clock in the morning hands froze they became rock solid. They were unable to move. After eating 2 tablets TYLENOL the hands where no longer rock hard but became numb. I went to sleep, and the fever went away. From yesterday till now I have had dizziness, headache, numbness. When I ate food this morning, I ate little and threw up most of it. At around 5 pm I got another fever and ate 2 tablets of TYLENOL and the fever started to go away.
Received FluMist @ 9:45 am 12/10/08. One hour later c/o dizziness, sore throat, throat swelling, hoarseness, cough. No SOB/resp distress. She went to ER where dx with "allergic reaction". Given pred, epi pen, benadryl, claritin w/relief of s/s.
This medically confirmed spontaneous report (initial receipt: 28-Sep-2012) concerns a female patient. On 24-Sep-2012 the patient received AFLURIA PFS (batch number was not provided) injection. Following vaccination, the patient developed injection site reactions. The reaction was described as being localised at the injection site 3 inches in diameter, red, hot and hard to the touch. The patient sought medical attention. The event outcome was recovering.
Within one hour post vax, the pt experienced ocular pain in his left eye which resolved within 24 hours. The physician stated that he believed the ocular pain was a symptom of ocular neuritis, but he was unable to confirm the diagnosis of ocular neuritis. this case is considered to be SmithKline Beecham medically serious. The most recent information, received, reports the condition of the pt is resolved.
Information has been received from a health professional via a drug wholesaler concerning a pt who was vaccinated with pneumococcal vaccine 23 polyvalent. It was reported that the pt contacted the office, post vax, and stated that his or her arm had begun to bruise. The pt had sought medical attention for the experience. It was reported that a pt had developed injection site erythema, post vax, with pneumococcal vaccine 23 polyvalent (see WAES 01102743). Additional information has been requested.
This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Covid vaccine administered 10 days too early/first Moderna dose received on 19Dec2022 and second Moderna dose received on 06Jan2023) and NO ADVERSE EVENT (No adverse event) in a 26-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 015B22A and 015B22A) for COVID-19 prophylaxis.     No Known drug allergy.    On 19-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 06-Jan-2023, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Covid vaccine administered 10 days too early/first Moderna dose received on 19Dec2022 and second Moderna dose received on 06Jan2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Covid vaccine administered 10 days too early/first Moderna dose received on 19Dec2022 and second Moderna dose received on 06Jan2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         They administered the second Moderna initial series too early. Instead of doing it at the 1 month or 28 days mark, they gave it at the 19th day mark. No adverse events reported.  Treatment medications were not reported.
Headache, Myalgia, Arthralgias, Fever, Chills, Fatigue, Injection site pain, Rigors, Neck stiffness/pain
The patient received the vaccine at 8:30 am.  Reported no issues with first vaccine. The patient reported driving and feeling lightheaded and heart started racing. The patient pulled over sat and walked around and felt better. Then got back in the car and kept driving, heart was racing again, couldn't move fingers, blood was pounding, fingers appeared white and numb. The patient called  911 and volunteer firefighter came, ambulance arrived and could move fingers again. Blood pressure was 136/104.  For 10-15 minutes fingers felt numb and tingly, light headedness, and heart racing all stopped. The patient drove home and was not taken to the hospital and felt weak and shaky for about an hour.
I had tear in my left eye that I had 5 treatments for. I had tearing on my retina. I went to my eye doctor; they said I had thin retina and they referred me to a specialist. This soon happened to the right eye as well. I have been doing laser eye treatments.
Information has been received from a licensed practical nurse concerning a 17 month old female with no know drug allergies who on 5/30/02 was vaccinated in the leg with Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (lot # 642243/0170M) and diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (site not reported). The nurse reported that the patient developed a knot, about the size of a quarter, at the injection site of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast). The child was treated with warm soaks to the affected area. The nurse reported that the patient's knot stayed hard for about one month. The patient sought unspecified medical attention. The nurse reported that several patients have had the same experience after vaccination with Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (WAES0207USA00219). Additional information has been requested.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 13:00 as dose 5 (booster), single (Lot number: GJ6665) at the age of 74 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.
The patient has a dark pigmented, raised bump where she was immunized. She also continues to have muscle pain in the arm 2 1/2 months after immunization.
circular 3 cm area of rash that is macular no papules or pustules present/The rash appeared around injection site 2 days after the vaccine; circular 3 cm area of rash that is macular no papules or pustules present/The rash appeared around injection site 2 days after the vaccine; Redness; itching; This is a spontaneous report from a contactable Physician. This Physician reported for a 14-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0217 and expiry date was not reported), via Intramuscularly, in Arm Left, on 02Jul2021 at 11:30 AM (age at vaccination: 14 years), as a single dose for COVID-19 immunization at Doctor's Office/Urgent Care. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient did not have known allergies. The family history included that two siblings had this reaction (circular 3 cm area of rash). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0186 and expiry date was not reported), via Intramuscularly, in Arm Left, on 10Jun2021 at 03:00 PM, as a single dose for COVID-19 immunization at Doctor's Office/Urgent Care. and Gardasil vaccine via Intramuscularly, in Right arm on OCT-2020 and on 29Jan2021 (at age of 14 years). The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 03Jul2021, the patient developed circular 3 cm area of rash that is macular no papules or pustules present. The rash appeared around injection site 2 days after the vaccine, redness, and itching. The adverse events were resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. Outcome of the events was recovered on 07Jul2021.  Follow-up attempts are completed. No further information is expected.
Product storage error; Poor quality vaccine administered; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Product storage error) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No concomitant medications were reported. No treatment medications were reported.  This case contains information for the 89 of 100 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Patient reported to my office complaining of eyes sporadically tearing, feeling dry, and reported that she had been having trouble since being hospitalized for her Hb dropping to 5 and that she has been having trouble with Hb stability ever since.  Patient states that she almost died in the hospital.  Upon questioning, the only difference in diet or medication was that the patient reported receiving the J&J covid vaccine a few days prior to being hospitalized.  Patient reports that she has a history of a blood disorder and transfusions.  Patient reports that nobody asked her about this prior to being given the vaccine.  Patient also reports upon questioning that nobody in the hospital asked her if she received a covid vaccine.
allergies bad; running nose; head was stuffy; sneezing; watery eyes; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergies bad), RHINORRHOEA (running nose), HEAD DISCOMFORT (head was stuffy), SNEEZING (sneezing) and LACRIMATION INCREASED (watery eyes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced HYPERSENSITIVITY (allergies bad), RHINORRHOEA (running nose), HEAD DISCOMFORT (head was stuffy), SNEEZING (sneezing) and LACRIMATION INCREASED (watery eyes). At the time of the report, HYPERSENSITIVITY (allergies bad), RHINORRHOEA (running nose), HEAD DISCOMFORT (head was stuffy), SNEEZING (sneezing) and LACRIMATION INCREASED (watery eyes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
I had mostly nausea and diarrhea.  It keep happening so I went to my doctor.  They told me to take over-the-counter medicine for it.
Pt recvd vax & 15 mins p/vax pain started down arm into the neck; also devel blotty skin under arm; pt was seen by MD & treated  w/DPH;
A report has been received from a Health Professional concerning a 9 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST started on an unknown date. The patient experienced numbness in feet, tingling in hands and feet, swelling at joints, blurred vision, left knee swollen, numbness in hands, left knee red and hard to bend and shooting pain which started on 08-Oct-2013. The outcome of the event of numbness in feet, tingling in hands and feet, swelling at joints, blurred vision, left knee swollen, numbness in hands, left knee red and hard to bend and shooting pain is unknown. The report was considered to be non-serious.
Pain in right arm, worsened over next two days.  Also developed dizziness and lightheadedness and felt like "crawling out of skin".
pt recvd vax 23MAR93 & was found to be pregnant; pt smoked 10 cigarette per day during pregnancy; while in seventh month of pregnancy devel hypertension; @JUN94 p/38 wks gestation delivered 6 lb 14 oz male; treated for jaundice;
It was reported that a female patient received a Fluzone SV '00-'01 vaccination on 28 Oct 2000. Reportedly the pt developed pain the same evening as dose was administered and described as "grabbing" pain. Turned into severe pain to where she was incapacitated. Soreness in chest from back spasms. Hurts to take a breath. Residual ache and back soreness on left, which was vaccine, site. Pt has had fibromyalgia for 15 yrs and this is not that kind of pain.
Began to ITCH all over, especially on his head-top and in and around ears.  Also, a rash, flat mostly but a few pimply spots on his torso.  Torso has this blotchy rash all over from neck to stomach and all over his back.  Dr. prescribed a cortisone cream to be applied 2x/day.  2nd Dr prescribed a benedryl cream to slather over his torso.   Severe itching and tingling comes and goes.
Shingles; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0153) via an unspecified route of administration in the right arm on 19Mar2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune hepatitis (AIH), mixed connective tissue disease, arthritis, hypertension (HTN), gastroesophageal reflux disease (GERD), obstructive sleep apnea syndrome (OSA), overactive bladder (OAB) and prediabetes (Pre-DM). The patient had allergy to penicillin and allergy to quinolones. The patient received unspecified medications for autoimmune AIH, HTN... within twoweeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the right arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. 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 01May2021, the patient experienced shingles. The event shingles resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event shingles and included treatment with VALTREX, gabapentin and FLEXIRIL. The clinical outcome of the event shingles was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
AREA RED APPROX. 10 CM WITH 5CM INDURATION AREA WARM AND SWOLLEN.  MOTRIN EVERY 4-6HRS AND BENADRYL 50 MG EVERY 6 HRS AND ICE PRN.
Grandmother:  brought child to clinic reporting child had reaction from shots giving on 12/12/18. Temp. 99.7(ear), alert and talkative. Grandmother reported child eating and playing good at home. Noted numerous raised dry scalped and open areas to bilateral cheeks, chin, neck, and upper extremities. Right arm worse than left arm. Grandmother reported constantly itching and scratching.
Over last 3 to 4 days, feels like certain ways she moves her shoulder hurts. Also notes intense pain and swelling at injection site and myalgias in proximal arm near shoulder; decreased shoulder movement b/c of pain.
At MC ? Presented to ER via W/C from clinic with severe progressive left lower extremity numbness, severe headache, and fever (101.3) at 1304 on 09/26/17. Nausea and vomiting followed began after ER admission. Labs drawn, PO and IV meds given for pain and fever. IV antiviral and antibiotics given. Medevaced to another MC at 0635 on 09/27/17. Medevac delayed due to weather. At 2nd MC ? Lumbar puncture and epidural blood patch performed.
Contracted SARS COVID 19 with positive result on 4/14/2021 after full vaccine series completed in January 2021
There was no adverse reaction, vaccine expired on 08/31/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 07-Sep-2021, Depression and Obesity. Concurrent medical conditions included GERD. Concomitant products included OMEPRAZOLE for an unknown indication.    On 17-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021). On 17-Sep-2021, EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.
Pt developed late stage Lyme disease; dx'd 10/00 and vaccinated for Lyme disease on 2/4/99, 3/17/00 and 5/16/00. Late stage symptoms worsened after the last dose. Also, developed autoimmune thyroiditis in early 2000. May have had undiagnosed Lyme disease prior to vaccination. Hyperprolactinemia also was dx'd in early 2000 but is improving now.
metallic taste in his mouth; his jaw began to hurt; sweating profusely; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age (reported as 40, unknown unit) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got his first Pfizer vaccine dose and "he immediately had metallic taste in his mouth, then his jaw began to hurt 30 min later and now he was sweating profusely." The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
same day of vax malaise, muscle soreness (especially lt side of back), sl soreness @ inject site (lt arm); next day (late afternoon)-pharyngitis, ear infect;
C/O cough, headache, runny nose or congestion, loss of taste and/or smell, and myalgia
Patient received second booster vaccine 8 days early of the 4 months date. No symptoms/adverse side effects
got the covid Pfizer plus they gave me the shingles; got the covid Pfizer plus they gave me the shingles; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant vaccine included varicella zoster vaccine (SHINGLE VACCINE) via an unspecified route of administration from an unspecified date for immunization. The patient went this past Monday he went to get the covid Pfizer plus they gave him the shingles, they said it was ok and everything. As soon Monday came he had a little bit of chills but that went away, and he had had a headache ever since Monday and that's been 6 days now. The outcome of the event chills was recovered and the outcome of the other events was unknown.  The lot number for the BNT162B2, was not provided and will be requested during follow up.  Follow up (26Aug2021): New information received from a contactable consumer (patient) includes reporter information.  Follow-up (07Aug2021): This case is being submitted to notify that the initial information for this case was first received by the Company on 07Aug2021 and not on 26Aug2021 as previously reported.
Large area of erythema to (R) upper thigh. No drainage. OTC antihistamine and BACTROBAN oint. TID x 5-7 days per office note.