chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; pain; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) and PAIN (pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced HERPES ZOSTER (shingles) and PAIN (pain). At the time of the report, HERPES ZOSTER (shingles) and PAIN (pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-085610, US-MODERNATX, INC.-MOD-2021-085610 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-085610:case for wife US-MODERNATX, INC.-MOD-2021-085610:case for husband
This spontaneous report as received from a medical assistant refers to a 4 month old infant patient of an unknown gender. On 16-MAY-2013 the patient was vaccinated with the first dose ROTATEQ (dose, route and lot # not reported). No adverse effect was reported. Additional information has been requested.
pain down my fingertips/experiencing pain at injection site; pain extending up to her shoulder; severe pain / ached all over my body; developed fever; headache; did not have any energy; This case was reported by a consumer via other manufacturer and described the occurrence of pain in fingers in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th February 2020, the patient received the 1st dose of Shingrix. In February 2020, 4 hrs after receiving Shingrix, the patient experienced pain in fingers, shoulder pain, general body pain, fever, headache and loss of energy. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the pain in fingers, shoulder pain, general body pain, fever, headache and loss of energy were recovered/resolved.   It was unknown if the reporter considered the pain in fingers, shoulder pain, general body pain, fever, headache and loss of energy to be related to Shingrix.  Additional details were provided as follows: At 1:00 pm, the patient received Shingrix vaccine and by 5:00 pm the patient was experiencing pain at the injection site and extending up to her shoulder and down to the fingertips. By late evening had developed fever, headache and severe pain.  The patient also mentioned that she did not have any energy and ached all over her body. The patient stated that the next day she took advil which eased the pain and that it took a full week to start feeling better. No further AE information was provided.
covid-19; Initial information was received on 04-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (patient's friend) via social media.  This case involves female patient (age unspecified) who had corona virus disease (COVID-19) while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.   On an unknown date in 2020, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in 2020, the patient had a non-serious corona virus disease (COVID-19) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Vaccine given while in car in parking lot. It was given incorrectly below the deltoid.. Resulted in pain redness and swelling and intense itching X 5 days, resolved & returned on day 8 & 9 ( bright red and intense itching) treated with Benadryl. Should dose be repeated?
Administered a punctured vial that was left in the fridge for 24 hours to at least 3 patients.; 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 (Administered a punctured vial that was left in the fridge for 24 hours to at least 3 patients.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a punctured vial that was left in the fridge for 24 hours to at least 3 patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a punctured vial that was left in the fridge for 24 hours to at least 3 patients.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. Treatment medications were not provided by reporter.
Began with earache 30 days after second vaccination and subsequent blisters at ear and chin.. Diagnosed with shingles and left side facial palsy (Bell's Palsy).
This case was reported by a consumer via (Shingrix GSK) interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 27th November 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received shot of Shingrix past Saturday (from the day of reporting), reported red swollen area around the injection site. The follow-up would not possible as no contact details were available.
pt recv vax 3DEC97 & 14DEC97 pt devel a localized rash that consisted of two vesicles that looked blister like around the site;
a 15 month female patient received only the DTaP component of the Pentacel/No AE; Initial information received on 21-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old female patient who only received the DTAP component of the HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ230AA, expiry date: 04-APR-2021 via unknown route in unknown administration site on an unknown date.  Medical history, concomitant, medical treatment, vaccination and family history were not provided.   It was an 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.
pt recvd vax 30MAR94 & w/in 24 hrs deve ax t103 & was sl irritable; fever resolved 1APR; however, 1APR pt devel macular rash on back, neck forehead & torso; rash worsened 2APR, resolved by 4APR; APAP given; no MD visit; pt recovered;
Case number PHEH2016US026328, is an initial spontaneous report received from a nurse on 07 Oct 2016. This report refers to a patient of an unknown age and gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619901) at a dose of 0.1 ml, intradermal on 07 Oct 2016. No adverse event was reported following this medication error.
Patient states that she has hives going down her arm to her wrists. She states the hives itch, but do not burn or cause pain. Patient states this is not from the adhesive allergy.
A few minutes after I got the first dose my fingers started to get tingly. I did not feel good, and people asked me if I was alright because I was pale. My heart rate was very high. I was observed for longer and my heart rate came back down. During the whole day I was still having palpitations for a minute or two at a time. It continued for about a week and my doctor advised that since it was intermittent and short lived it was OK. I had the second dose and I just felt feverish for one day and a headache for a couple of days.
Fever and rash on legs on 4/7/16, resolved. Developed new rash/low grade fevers on 4/17. Rash was "blistery" and spread to legs, arms, buttocks, hands/feet, around mouth. Seen on 4/18 for papular rash.
On 11/23/2021- at 07:00 AM ,  I was achy and I had a slight fever and it was sore around the injection site. The next day my fever was 100.4 to 100.6 and I had a swollen lymph node under the arm I received my vaccination on. I called the clinic. They told me to watch it and  if the lymph node did not go down within 7 days, I should be seen.  By the 5th day I was much better. The fever only lasted 2 days after the shot.
Pain at left deltoid injection site (4/10) beginning 3 hours post-injection on D1, maximum 5 hrs post, began resolving next morning (D2); resolved by D3.   On D2 early a.m., severe exacerbation of gout symptoms (pain and inflammation both went from 2/10 to 8/10), sufficient to awaken me  from pain. Affected joints were left MT-P #2-5. Improved to 4/10 by D3, and 3/3 by D4 where stabilized at since (now D28).  Severe new pain at left deltoid injection site (pain 8/10) on D27 late, sufficient to awaken  me before alarm. Left arm function compromised--unable to put on t-shirt, unable to lift coffee cup, unable to lift laptop computer, unable to raise stretched arm to shoulder level.  No overt local swelling, redness, or heat. Pain was deep intramuscular, not tender to touch, elicited by firm finger pressure or any motion involving deltoid muscle contraction. Pain and arm function improved on D28 to 4/10 arm pain. Necessitated rescheduling 2nd Moderna injection set for today.
I received my first Pfizer booster for COVID-19 on 9/15/2021. Early in the morning on 4/11/2022, I developed a sore throat and runny nose. I then developed fatigue and muscle aches. On that day, I took a rapid test at work and got a positive result. I then went home and did a telehealth visit with my PCP, who prescribed me PAXLOVID. After the second day of taking the PAXLOVID, my symptoms improved. By 4/15/2022, my symptoms were gone. I was then able to return to work on 4/18/2022.
A 43 year old female reported that she received an IM injection of influenza virus vaccine in 2002 and experienced "a red knot under her arm that would itch for several days and then resolve." The pt reports she has history of a possible allergy to preservatives. The pt previously experienced a more severe reaction of "a red knot under her arm that would itch for several days and then resolve," in 2000 and 2001 after receiving influenza virus vaccine. She reported the reaction was less severe than with previous injections because the injection site was rubbed with a cotton swab after the vaccine was administered. She recovered. No additional info was available at the time of this report.
Pain and large red and purple (about 3.5 inches by 4.5 inches) mark at or near injection site. Large hive covering the outer red exterior 2 weeks after vaccine.
Pt c/o mild raised rash to neck chest and upper back and bilateral mild swelling . took one dose of benedryl and tried hydrocortisone cream without relief presented to office today with continuing symptoms given 40 mg kenalog im  and 20 mg prednisone bid for 5 days
Pain in arm immediately. No sign of redness or swelling. No heat to touch. Pain lasted two days with some neck pain associated.
SC DAY AFTER VACCINES- FATIGUE,FEVER,CHILLS, SLEEPING 12 HRS A DAY X 2 WKS, DOUBLE VISION 2 WKS LATER, (R) PERIPHERAL VISION LOSS WHICH CON'T X 6-8 WKS AFTER VACCINES, SEEN BY MD 2 WKS AFTER VACCINES BUT NO TESTS DONE AND DID NOT COMMENT THAT SX WERE VACCINE RELATED --VACCINES REQUIRED BY NURSING SCHOOL
1 day p/vax pt c/o itching @ the site of Acel-Imune administration; 2 days post vax pt devel redness, swelling & warmth @ the site of Acel-Imune administration;this is 1 of 4 pt from this site to devel an inj site rxn p/vax;
Partial hearing loss, ears are very cloudy feeling.; Partial hearing loss, ears are very cloudy feeling.; I also experience dissociation regularly but the vaccine seems to have made it more common.; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 26May2021 at 12:45 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder, anorexia nervosa and dissociation reaction. Concomitant medications taken within two weeks of vaccination included lithium (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B12), echinacea spp. (ECHINACEA), calcium (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN) and biotin (MANUFACTURER UNKNOWN), all from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27May2021 at 08:00, the patient experienced partial hearing loss, ears had very cloudy feeling. The patient also experienced dissociation regularly but the vaccine seemed to have made it more common. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events partial hearing loss, ears had very cloudy feeling, also experience dissociation regularly but the vaccine seemed to have made it more common was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022; product storage error; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event) in a 49-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, 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 21-Dec-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event) outcome 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 TEMPERATURE EXCURSION ISSUE (excursion started on 15Dec2022 HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022) and PRODUCT STORAGE ERROR (product storage error).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medications were reported.  It was reported that the excursion took place on 15-Dec-2022 through 27-Dec-2022. Maximum temperature reached was 46.5 , cumulative duration of excursion was 19.3 hours.  HCP reported that they gave 16 doses of the vaccines between the 15-Dec-2022 and 21-Dec-2022 and then following that the vaccines were marked to not use. There were no reports of side effects had been reported to them. No treatment details were reported.
Several hours after receiving  the shot my heartrate went to 140 beats per minute for the better part of 2 days. I was dizzy and on the verge of passing out. My PVCS returned.
noticed reddening of ears & red patches around mouth & chin appeared to have disappeared by bed-time;@ 245AM 25AUG96 awoke w/t102.2 gave APAP sat w/ her for 1hr;awoke uncomfortable & red from head to toe @ 345-4AM;to ER for epi;fever & spot
NICKEL SIZE DARK PINK RAISED AREA AT INJECTION SITE NO PAIN NO TREATMENT
Lightheadedness; Developed nausea that lasted 20 min and was improved with emesis and laying down .Patient was observed by EMS and patient made full recovery .
23APR92 problem w/speech on 24APR92; pt taken to hosp 25APR92 uvula deviates lt assume IX or X nerve palsy; gradually recovered w/no rxn;
Developed a hissing and ringing in the ears.  (Tinnitus) around 9:30PM the same day I got the shot. Never had symptoms like those before. And the ringing has continued and remains to this day at the time of report. With no improvement.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Severe,
THROAT SWELLING; BODY ACHES; STOMACH ACHES; CHILLS; DIZZY; SEVERE HEADACHE; FEVER; INJECTION SITE BLEEDING; MILD SHOULDER PAIN; INJECTION SITE "BUBBLED UP"; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included many surgeries post traumatic car accident, and concurrent conditions included a lot of scar tissue on shoulder (at injection site), and high blood pressure.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A2114, and expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced injection site bleeding. On 18-MAY-2021, the subject experienced mild shoulder pain. On 18-MAY-2021, the subject experienced injection site "bubbled up". On 19-MAY-2021, the subject experienced dizzy. On 19-MAY-2021, the subject experienced throat swelling. On 19-MAY-2021, the subject experienced body aches. On 19-MAY-2021, the subject experienced stomach aches. On 19-MAY-2021, the subject experienced chills. On 19-MAY-2021, the subject experienced severe headache. On 19-MAY-2021, the subject experienced fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from injection site bleeding, and injection site "bubbled up" on 18-MAY-2021, and mild shoulder pain, was recovering from severe headache, throat swelling, fever, chills, and body aches, had not recovered from dizzy, and the outcome of stomach aches was not reported. This report was non-serious.
Extreme exhaustion, severely painful arm (injection arm), headache, body aches, dizziness.
Hives over torso & neck - progressed over 2 days before reported. BENADRYL 25 mg x 2 doses resolved.
4cm area of redness and induration at left arm injection site. (Varicella Site)
A few months after receiving  the Janssen Covid-19 vaccine on 5/24/21, the patient underwent a bone marrow transplant. Patient's doctor recommended revaccination with the Moderna series from scratch due to immunosuppression from transplant. First dose Moderna vaccine of 0.5 mL was administered on 12/18/21 based on  pharmacist's clinical judgement. To date, patient has not experienced any adverse events from first Moderna vaccination.
No immediate arm pain. Woke up at 3:00 a.m. the next morning with a 101.2 fever, chills, muscle aches throughout entire body. Severe headache as well. I took Advil and Tylenol which helped but fever stayed all that day at 100.6. Slight cough, and I kept getting the hiccups. Now I'm on day two and feeling better, but still fatigued and achey.
Skin infection at infection site. Unsure if due to vaccine or environmental causes. Large red and warm rash, fever, pain and discomfort appearing exactly one week after vaccination, rash measuring 3"x2"
fever persisting for 5 days; red spots on skin appeared 48 hours after receiving vaccines. (not sure if either symptom is related to vaccines)
the tingling came back and it was very intense; I got my period down again, three days after exactly like the first vaccine and my period has been worse; This is a spontaneous report from a contactable consumer.   A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2, via an unspecified route of administration on an unspecified date (Batch/Lot Number: ER8736) as 2nd dose, single for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 on an unspecified date (Batch/Lot Number: ER8736) for COVID-19 immunisation and experienced as stated, "the first day, I got the vaccine about two to three hours after getting  the vaccine, I started having tingling all over my body and by Friday, I started having pain and then it started messing with my nerve and it got really bad. I went to the emergency room and they tried to give me some medication and I took some. So, I didn't like the way I felt, so I stopped thinking that. When I went to Emergency Room (ER), the doctor are telling me that these are the unknown side effects because these are not the ones that they heard of but I heard that they talk about that you could have a rare side effect and I am telling you that, that is the only thing that I heard, this is what happened to me. Also, three days after I got the first vaccine, my period came even though I already had period in that month and they said it could be a coincidence. So, they automatically set up my second shot four weeks later and I was using a natural stuff for the pain and the tingling and all that sort of things. Three weeks after, everything was the same, nothing has changed, it was like common cold and then I felt better because of that natural stuff that I was using, it helped me feel better.  So, I went and got my second vaccine and this was on this last Saturday, I got my second vaccine, the tingling came back and it was very intense and then I got my period down again, three days after exactly like the first vaccine and my period has been worse. So, I am calling you, I even called CDC trying to get information and everything, then I got this number to call you guys and I called." The outcome of tingling was unknown and other event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021484439 same patient, similar event, different dose