chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bilateral lower extremity paresthesias; transverse myelitis; CNS demyelination; idiopathic neuropathy; poliomyelitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or around 06-JUN-2011 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date (reported as shortly after the vaccination), the patient suffered numbness in the legs and experienced multiple hospitalizations where she was ultimately diagnosed with bilateral lower extremity paresthesia, transverse myelitis, central nervous system (CNS) demyelination, idiopathic neuropathy and poliomyelitis. As a direct and proximate result of vaccine live(ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using vaccination. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of vaccine live(ZOSTAVAX) patient suffered severe, serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcoem of events was considered as not recovered. The reporter claimed the events were related to zoster vaccine live(ZOSTAVAX).   Upon internal review, transverse myelitis, central nervous system (CNS) demyelination, idiopathic neuropathy and poliomyelitis were determined to be medically significant. All the events were considered as disabled according to the reporter.
Have had constant sinus pressure and congestion since getting the vaccine. It hasn?t resolved. I thought it was an ear infection at first, so I took a 14 day run of augmentin. But it hasn?t resolved. Nothing in my diet or medication regimen has changed. 3-4 days after I got the vaccine these symptoms started. Breathing also feels more labored. I can?t drink coffee anymore because it makes me want to pass out. The only thing that helps is pseudoephedrine. I?m seeing a specialist and they are having trouble figuring out what?s wrong.
No additional AE; Nurse reporting MMRII was administered one day after expiration. No additional AE. No PQC.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medial history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 06-OCT-2022, the patient was vaccinated with one day after expiration measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant human albumin (rHA)) 0.5 mL,  lot # T033814 with expiration date 05-OCT-2022, for prophylaxis (strength, route of administration and anatomical location were not reported). No additional adverse event (AE) was reported.
1 week after receiving 2nd vaccine 8 started to have tachycardia, palpitations, flutters. It has also been a little harder to breath. I got a ZIO monitor placed 2/5/2021 to monitor my episodes.
This spontaneous report was received from an "other" reporter referring to a patient of unreported age and gender. The patient's relevant medical history, drug reactions or allergies, and concomitant medications were not provided. On 01-NOV-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) 0.5 milliliters (ml) for prophylaxis after a temperature excursion (lot number U002529, expiration date 24-AUG-2022). The vaccine underwent a temperature excursion of minus 10 (-10) degrees Celsius (C) for 7 hours. There was no previous temperature excursion. No additional adverse events (AE) were reported (no adverse event).
High fever lasting 3 days. Extreme irritability, loss of appetite, otitis media, croup like cough.
This was the Moderna vaccine, which I had reaction to the first shot on 2/27/21.  I had listlessness, fatigue, cold/flu symptoms, etc.  With the second shot on 3/29/21, I didn't seem to have as much of a reaction, but then I started getting diarrhea, and a flare in my Crohn's.  Since then I have had abdominal spasms, bleeding (as if I was on blood thinners), increased bowel urgency, several bowel accidents, stomach pain, and severe fatigue.  I have contacted my doctor for assistance in my treatment but thought I should report this in case it was a response to the vaccine.
Immediately after the pt received her 2nd dose of the COVID19 vaccine she reported feeling tingling down her left arm from the injection site down to her 2-5th digits.  No weakness noted. Pt assessed by observation volunteer staff. Normal vaccination site, normal neurovascular exam. BP 130/100 HR 63 RR 16 O2Sat 99% , repeat BP 129/96. EMS evaluated was recommended to which pt declined. Pt was advised on ED precautions and to follow up with her PCP asap. Prior to leaving the pt reported symptoms seemed to be getting better but were not fully resolved. Pt verbalized understanding and agreed to the POC.
FLUSHING, TINGLING OF BODY, BLURRY VISION HEADACHE, CHEST TIGHTNESS + PRESSURE.  TOOK BENADRYL 20MG INITIALLY AT 4.  MEDROL DOSE PACK STARTED IN A.M. AFTER SWELLING TO FACE, EYES, MOUTH (FACIAL EDEMA)
Started in the evening of the 24th, I had a very sore swollen throat. Next day, about noon, I had a cough and severe congestion. Still painful swollen sore throat. By that evening, my chest was tight and I was having difficult breathing because of swollen throat. I called doctor, 26th, and got some meds. He gave me Singulair and Flonase and a cough suppressant - Benzonatate.  I am almost back to normal today - just still have some congestion and a little bit of a cough.
pt recv vax in 1989 & in FEB96 was found to have an elevated ANA titer (1280 homogenous, 1:180 speckled) & an elevated C4 complement;
This spontaneous report was received from a registered nurse referring to a 23 year-old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided.    On 07-DEC-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N004799, expiration date on 15-NOV-2019 or lot #N021475, expiration date on 21-JAN-2020, for prophylaxis (strength and route were not reported). The vaccine was stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA002510: US-009507513-1801USA002511: US-009507513-1801USA002512: US-009507513-1801USA002513: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1801USA002509: US-009507513-1712USA010085: US-009507513-1801USA002514:
(L) UE - increasing redness, burning, fever/chills, nausea.
1st dose- nausea, extreme fatigue, muscle aches, joint pain, fever, headache  2nd dose- headache, nausea, fatigue, muscle aches, joint aches, headache
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Additional Details: PATIENT STATING AFTER RECEIVING COVID VACCINE ON 5/31/21 SHE IS STILL EXPERIENCING PAIN IN MUSCLE WHERE INJECTION WAS GIVEN.
patient rec'd grey cap pfizer vaccine after it was in the freezer for 22 days- pt wants replacement dose at some point
Patient accidentally received a seasonal flu vaccine after having already received a seasonal flu vaccine on 9/22/23. Provider ordered in error.
got sick to stomach; got really lightheaded & dizzy, felt like that all day & noc;lt arm swollen up really bad & turned black & blue
This spontaneous report as received from a physician via a company representative refers to a 4 month old patient. Pertinent medical history, drug reactions or allergies were not reported. On 06-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot number were not reported) instead of PREVNAR. Concomitant medication was not reported. No adverse effects were reported. Additional information has been requested.
pt reported exp episode Tuesday noc @ approx 10PM c/o h/a et itchy feeling;pt transported to hosp ER via EMS;tx for inc BP on 180/100 sl rash on upper extremities;MD prescribed pred x 3 days;
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2022, the patient received the 1st dose of Shingrix. On 1st March 2022, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's spouse. The patient received her first dose of Shingrix and experienced a sore arm for a few days and had resolved. The reporter did not consent to follow-up. This case has been linked to US2022042578, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022042578:same reporter - different patient
felt tired; She had the Pfizer COVID vaccine and had pain and suffering; had on Sunday morning a leg cramp and she doesn't think that is a vaccination side effect; This a spontaneous report from a contactable consumer. This consumer reported for herself that. A female patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not provided) via an unspecified route of administration on 03Jul2021 as single dose for COVID-19 immunization. Medical history included cramps in uterus, pelvic pain, cramps in the brain, cramps in the calves in her legs and mentions she has a fracture and has bleeding and intentional injuries. Concomitant medications were not provided. On 04Jul2021, felt tired, She had the Pfizer COVID vaccine and had pain and suffering and had on Sunday morning a leg cramp and she doesn't think that is a vaccination side effect. It was reported that Caller says that she was trying to explain to this agent that she got the vaccination, the 1st dose, on Saturday and then on Sunday she felt tired, which was a normal effect, but also she had on Sunday morning a leg cramp and she doesn't think that is a vaccination side effect. It was a severe leg cramp on her left calf. Caller begins to get loud and hard to understand. She thinks that it was because of the location where they put in the needles and that causes that type of pain and suffering. Caller becomes irate and yells that this was not a vaccination side effect. She remains irate and says just do whatever, she doesn't believe that this was a side effect. She had the Pfizer COVID vaccine and had pain and suffering and that was not a side effect of any vaccination. Caller begins to yell at this agent, and an attempt was made to calm down caller. Caller states, whatever miss, whatever and she says that this was no side effect. She says she tried to explain this to someone, and they said to take Tylenol for the pain before. She is having pain and suffering. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Blood clots in the left leg, same side as the vaccine was given.  Woke up approximately two days afterward  (2/11/21) with muscle pain in the left thigh. The pain did not lessen over the week, assumed it was just muscle. The pain migrated down to my calf and then was too painful to stand on or walk on 2/18/21.
Initial and follow up information has been received from a physician concerning a 51 year old female nurse with sulfonamide allergy who on 19-SEP-2007 at 02:30 PM was vaccinated in the arm with a first dose of Pneumovax 23 lot #658075/0962U. Concomitant therapy included alprazolam (XANAX) and escitalopram oxalate (LEXAPRO). The physician reported that on 19-SEP-2007 the patient experienced "bad injection-site reaction which included pain, warmth, redness and welts/hives surrounding the injection site". In follow up it was reported that on 20-SEP-2007 at 06:00 PM patient developed several scattered areas of redness and swelling with tenderness in her left upper arm. She was prescribed oral steroids (unspecified) and over the counter (OTC) antihistamines and compresses to treat symptoms. Patient recovered on 22-SEP-2007. The reporter felt that getting oral steroids (unspecified), over the counter (OTC) antihistamine and compresses to treat symptoms was to prevent patient from being serious and considered this as a serious other medical event. Additional information is not expected.
Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female who "several months ago" (in approximately 2010) was vaccinated with the second dose of GARDASIL (route and lot # unspecified). The physician reported the patient "just discovered" (on 01-MAR-2011) she was "2 weeks pregnant" (estimated last menstrual period on 17-FEB-2011 and estimated delivery date on 24-NOV-2011). Additional information is not expected.
Sore arm//had very mild side effects from the first vaccine; Mild fatigue/had very mild side effects from the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm//had very mild side effects from the first vaccine) and FATIGUE (Mild fatigue/had very mild side effects from the first vaccine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Patient never have tested or diagnosed positive for COVID. Patient not had any Acute and Chronic /long standing health conditions at the time or up to 1 month before vaccination. Patient did not receive any vaccine on the same day of moderna vaccination. Patient never had any side effects from any other vaccines.  Concurrent medical conditions included Penicillin allergy. Concomitant products included CALCIUM for Calcium supplementation, VITAMIN D3 for Vitamin D supplementation, MULTIVITAMIN [VITAMINS NOS] for Vitamin supplementation.    On 22-Mar-2021 at 12:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Mar-2021 at 6:00 PM, the patient experienced PAIN IN EXTREMITY (Sore arm//had very mild side effects from the first vaccine) and FATIGUE (Mild fatigue/had very mild side effects from the first vaccine). On 23-Mar-2021, PAIN IN EXTREMITY (Sore arm//had very mild side effects from the first vaccine) and FATIGUE (Mild fatigue/had very mild side effects from the first vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       There were no other potential causes for adverse events.  Patient was concerned about the long-term effects and consequences of having received a full dose instead of half dose as a healthy person. Patient did not seek medical care.  No treatment medication were provided.   This case was linked to MOD-2021-405083 (Patient Link).
10.27.2021  local itching at L deltoid  1 hour after injection, progressed to redness, swelling, warmth , went to urgent  care  then directed to emergency department,  given IM corticosteroid  & discharged with oral naproxen & antibiotics
SWOLLEN LEGS; This spontaneous report received from a patient 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 and has been requested. No concomitant medications were reported. On MAY-2021, the patient experienced swollen legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen legs. This report was non-serious.
No swelling. Pain at site of injection that progressed along entire arm and down to wrist.  No fever.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 at 12:00 as dose 1, single (Lot number: EL9268), in right arm, on 04Mar2021 at 12:00 as dose 2, single (Lot number: EN6205), in right arm and on 30Sep2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Antihistamines" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Keflex, reaction(s): "known allergies: Keflex". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19; COVID 19 Treatment Paxlovid from 08Aug2022 to 13Aug2022.  No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19 are related to BNT162b2 (COMIRNATY) cannot be excluded.  The vaccine efficacy varies from one patient to another and can be affected by different factors. This case will be reassessed should additional information become available.
5 days after vaccine began having difficulty breathing, tightness of chest, chest pain, and feeling like something very heavy was sitting on chest. Has now been 3 months and symptoms have not subsided. I was a very healthy and active woman prior to the vaccine with no respiratory issues preceding vaccine.
Information has been received from a nurse practitioner concerning a 17 year old female with amoxicillin allergy and no pertinent medical history who on 10-SEP-2007, 12-NOV-2007 and 14-MAR-2008 was vaccinated with a first, second and third 0.5 mL doses, respectively, of GARDASIL vaccine (Lot #658488/0930U, 658558/1061U, 658488/1264U respectively). There was no concomitant medication. After receiving the third dose of GARDASIL vaccine the patient experienced unnamed symptoms. Subsequently, the symptoms cleared and then after an unknown time she experienced the symptoms again. Her family doctor diagnosed shingles for both occurrences. At the time of the report, the patient had recovered from shingles. The patient was seen in office. Additional information has been requested.
Loss of balance, sore arm at injection site, intense pain in stomach. Healthcare provider diagnosed patient with gastritis.
Mild allergic reaction. Soreness in left arm, redness in left arm. Pt took ibuprofen for pain.
Patient came to clinic today 4/10/2023 to ask for her second primary COVID injection. RN reviewed chart that pt only received 1 Moderna Bivalent Booster on 3/9/2023. Pt says that was the first of the COVID series she has received. Per CDC guidelines, that a Primary Monovalent needed ASAP, referred pt to get that done in outside facility since we currently do not have any primary series vials. Variance report will be written within our facility. Pt educated and informed of vaccine error and understands to get Primary Monovalent ASAP. Pt did not report any adverse reactions.
Presented to ED w c/o AMS, w/cough & SOB; COVID PCR positive; admitted for pneumonia d/t COVID-19 & metabolic encephalopathy; tx w/abx, steroids, remdesivir, zinc. DC'd home on hospice.
Narrative:  82 yOM vaccinated x 2 with Moderna vaccine (1st dose 2/4/2021, 2nd dose 3/5/2021) who was admitted on 1/11/22 for treatment of COVID-19 pneumonia after having cough, sore throat, and body aches X 2 days. He was treated with remdesivir x 4 days of treatment due to a small increase of LFTs. He was discharged home on 1/14.
This case was reported by a nurse via sales rep and described the occurrence of swelling arm in a 66-year-old female patient who received SHINGRIX (batch number 27K24, expiry date unknown) for prophylaxis. On 7th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling arm and injection site pain. On an unknown date, the outcome of the swelling arm and injection site pain were recovered/resolved. It was unknown if the reporter considered the swelling arm and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient experienced after vaccination arm swelling and pain at the injection site. Her arm stayed sore for 3 to 4 days. She did not seek medical attention. The nurse did not agree to followed up. For tolerance to next dose, refer case US2018GSK190783.
After being vaccinated, I developed a severe sensitivity to onions (cooked and raw), garlic (cooked and raw), chocolate, and artificial ingredients. When I eat these things I develop dizziness, I can't walk and I develop a headache.
Menses irregularity. Menses came early and was heaviest of my life. Would be constituted as menorrhagia. Could not sleep through the night without accident. Using new sanitary device once and hour for multiple hours a day. Included large clots, silver dollar in size. Menses lasted for three weeks. And every month thereafter has lasted just as long.
After administration, patient  mentioned injection site pain. While waiting for 15 minutes, he said pain got worse, became pale, sweating, nauseous, lethargic. Was able to talk and conscious. EMT checked vitals and BP, pulse, O2 saturation were all within normal range. After about 30 minutes, patient felt much better (was able to move arms, not feeling dizzy, walking and talking well). Didn't have this issue in the past.
pt recvd vax & exp n, headache, general malaise & devel diarrhea
Dizziness, Myalgia, Arthralgia, Fever & NauseaVomiting Narrative:  dose 1 day 1-2 nausea, vomiting, fever 101.2, myalgia,  arthralgia; day 1-9-red/swollen/painful inj site dose 2 day 1 pain at inj site;  fever; chills; nausea/ vomiting; fatigue; myalgia; dizzy
103 degree temperature for 5-6 days, nausea, muscle aches, rapid heart rate, entire upper arm swollen and hot and painful with redness encompassing almost entire upper arm. I called my Doctor on 2/31/21 and had a Telegraph appointment. He ordered a tapering dose of prednisone. On 4/3/21 I called him after hours and he ordered an extra 20 mg of prednisone because the redness had continued to spread and he extended the prednisone taper.  The fever broke on 4/2/21 after using Tylenol every 6 hours for a week. My arm started to improve on the prednisone after a few days. I saw my Doctor in person on March 18 and there was still some red blotchiness in my arm. My doctor recommended that I not get the second dose.