chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 month old, received Havrix; This case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received HAV (Havrix) for prophylaxis.   On 23rd November 2022, the patient received Havrix. On 23rd November 2022, unknown after receiving Havrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 23-Nov-2022 Reporter's comment: The physician's office observed the patient for extra time, but did not report any adverse events. The reporter did not consent to follow-up. Additional supportive information: The patient was accidentally administered Havrix on the day of reporting at inappropriate age, which led to inappropriate age at vaccine administration.
I didn't have any symptoms. I wanted to have a bone density test for a baseline. My results showed Osteoporosis in my L1-L4 vertebrae and Osteopenia in my hip and neck. The doctor prescribed 1500mg of calcium and 5000iu vitamin D3 per day. The doctor also put me on FOSAMAX, one pill per week, but it gave me heartburn and bone and joint pain. I stopped taking it.
Unsure if this is related to the vaccine, but I developed Gout on June 8th as diagnosed on June 11th at an urgent care facility and later confirmed on June 22nd by a podiatrist.
The pt developed localized redness, warmth, swelling and itching. The pt also experienced fever of 99.6 and dizziness.
2 hours after vaccine - headache, weakness, skin red from head to knees (appearance of sunburn). 9/7 arms and face still red c/o slight headache, tired, increased sweating. 9/8 AM red.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccination with FLUARIX, (GlaxoSmithKline).  In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown).  In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint.  The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site.  At the time of reporting the outcome of the events were unspecified.  For the other 79 linked subjects please see cases: A0756483A - A0756511A, A0756513A - A0756562A.  The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A.  With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA).  On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA) : AFLUCA320, AFLUA320A, and AFLUA320B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA.  On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
If vaccine received Yes/vaccine brand=Pfizer / BioNTech/product=COVID 19 Treatment, brand=Paxlovid; If vaccine received Yes/vaccine brand=Pfizer / BioNTech/product=COVID 19 Treatment, brand=Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 12Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF8841) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "Psoriatic Arthritis" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Apr2022, outcome "unknown" and all described as "If vaccine received Yes/vaccine brand=Pfizer / BioNTech /product=COVID 19 Treatment, brand=Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: I still have and I am still testing positive; (unspecified date) negative, notes: I tested negative a few days after treatment; (29Apr2022) positive, notes: testing positive 3 days later on 29Apr. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid from 20Apr2022 to 24Apr2022.  Clinical course: The patient did not receive other medication in 2 weeks of vaccination. He had tested negative a few days after treatment then started testing positive 3 days later Friday evening 29Apr. But it was not until Saturday morning, 30Apr that he started experiencing COVID symptoms again. The patient was treated with Paxlovid from 20Apr2022 to 24Apr2022. He woke up with bad congestion and a cough which he still had, and he was still testing positive.   No follow-up attempts are possible. No further information is expected.
Fever up to 100.4 for three days.  Chills for one day.  Very sore arm for one day.  Fatigue for one day.
Cold symptom; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold symptom) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included SOTALOL, HYDROCHLOROTHIAZIDE, Parvo statin, POTASSIUM, LEVOTHYROXINE, OMEPRAZOLE, AMLODIPINE and SULFANILAMIDE (VITAMINDERMINA) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced NASOPHARYNGITIS (Cold symptom). At the time of the report, NASOPHARYNGITIS (Cold symptom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-067304, US-MODERNATX, INC.-MOD-2021-067247 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067304:Crosslinked (family member) US-MODERNATX, INC.-MOD-2021-067247:Crosslinked (family member)
BEGINNING 11/27/19 PATIENT HAD REDNESS, SWELLING AND PAIN AROUND INJECTION SITE. PATIENT STATES ONLY PAINFUL WHEN TOUCHED. PATIENT STILL HAVING SYMPTOMS AS OF 11/29/2019.
PT REPORTED FEELING A PAIN IN ARM UPON INSERTION OF NEEDLE AND INJECTION OF VACCINE THAT DID NOT SUBSIDE.  LATER IN THE EVENING SHE REPORTED THAT ARM WAS STILL VERY PAINFUL AND SAID IT WAS LIKE A NERVE PAIN. SHE SAID SHE WAS THINKING OF GOING  TO THE EMERGENCY ROOM BECAUSE SHE DID NOT FEEL SHE COULD GET THROUGH THE NIGHT WITH THE PAIN.
A non-serious, spontaneous report of administered expired product was received from a nurse concerning a nine-year-old male, subsequent to FLUMIST. The patient received FLUMIST on 20-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event  is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information received on 31-Mar-2009: included Product Complaint Investigative results.
Information has been received from a licensed practical nurse (LPN) concerning a patient who on approximately 20-MAR-2008 ("in the last 2 weeks") was vaccinated with a 0.5 ml dose of MMR II (lot number and site not reported. It was reported on an unspecified date, that these three patients were experiencing a fever, rash and injection site erythema after receiving MMR II. The patients were reported as recovered on an unspecified date. There was no product quality complaint. Follow up information was received on 11-APR-2008 from a nurse who reported that she did not know the names of these patients and there was no hospitalization. This is one of several reports from the same source. Additional information has been requested.
4/9/2022- Presents to ED, c/o SOB x 3 days. D-Dimer:305, WBC: 18.9 CXR: Right sided infiltrates.  On 4L via NC, 93% sat. Admit hypoxic respiratory failure due to Covid-19. Start ceftriaxone, azithromycin and decadron.  (was hospitalized last week here for R L extremity weakness, encephalopathy possible seizure/stroke, noted to have ischemic changes. Left heart cath, WNL).  4/10/2022 Continue Decadron, remdesivir added. Azithro changed to doxycycline given QT interval. Heparin SQ held, blood mixed with stool (has known bowl lesions she go to Facility for) H&H stable. Holding heparin.  4/12/2022- H/H stable. Weaned down to 1L NC 96% sat.  4/14/2022- Improved, on RA.  No further rectal bleeding noted. D/C home.
RASH DEVELOPED ON TORSO/SIDES OF NECK/EARS ON 4/9 THRU 4/13--ITCHY AT END OF COURSE. ALSO SWOLLEN LYMPH NODES RESULTING IN BRUISING
This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3247; Expiration date was not reported) via an unspecified route of administration, administered in the left arm on 10Feb2021 11:30 (at the age of 31-years-old) as second dose, single for COVID-19 immunization at a workplace clinic. The patient's medical history was not reported. Concomitant medication included norethindrone taken for an unspecified indication, start and stop date were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3247) via an unspecified route of administration, administered in the left arm on 19Jan2021 11:30 for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. No other vaccine was given in four weeks. The patient was not Covid positive prior vaccination and was not tested for Covid post vaccination. On 10Feb2021, on the night of receiving the second dose, the patient experienced chills and could not sleep for the entire night. On 11Feb2021, the next day, the patient experienced bad headache which made it difficult to stand up, her entire left arm (the arm where she got the shot) was swollen. On 14Feb2021, on the third day after her shot, the patient had irregular menstrual spotting, which was one week before her period. It was reported that she has a regular and consistent cycle but this menstrual spotting is unusual for her cycle. No treatment was given for the events. The outcome of event entire left arm (the arm where she got the shot) was swollen was recovered on 14Feb2021 (reported as for approximately three days); the outcome of the other events was recovered on an unspecified date in Feb2021. No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot# not reported) while she did not know that she was pregnant. The patient had a miscarriage. Unspecified medical attention was sought. At the time of this report, the patient's outcome was not reported. Miscarriage was considered to be an important medical event by the reporter. This is one of several reports from the same source. No further information is available.
Information has been received from a physician concerning a female who in October 2006, was vaccinated with the first dose of Gardasil (yeast) (0.5mL). In approximately October 2006, "shortly after the injection", the patient was examined and learned that she developed an abnormal PAP. Unspecified medical attention was sought. No further details were provided. Additional information has been requested.
Patient reports "feeling tired and achy after receiving vaccines." Reports having "red spots on stomach 7-10 days after vaccines."  Went to physician and was diagnosed with Shingles per patient. Was given Antiviral medication.
Vaccines given 10/22/07 On 12/24/07 developed projectile vomiting and dizziness lasting until 10/29. Still with dizziness. No fever
Pt received another Fluad flu vaccine 10/18/2021 after having already had at the clinic 9/3/2021.  Verified with pharmacy vaccine was administered.  No known adverse reactions or outcomes to patient.
This spontaneous report was received from a registered nurse refers to a patient of unknown age. On 22-JUL-2013, the patient was vaccinated with an expired dose of ROTATEQ (lot # 1710AA, expiry date 11-JUL-2013) route was not reported. Concomitant medications were not reported. No adverse effect was reported. Additional information has been requested.
rash on my forearm; got itchy hands and feet; This is a spontaneous report from a contactable consumer (patient). A 20-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration on 21May2021 (at the age of 20-years-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date as dose 1, single for COVID-19 immunization. The patient reported that she got his second dose on 21May2021 and 3-4 hours after he 'got itchy hands and feet'. Then she got a 'rash on her forearm' on 22May2021, but it went away within 30 min. She wanted to know whether it was common and whether was there anything that she could do for it. The outcome of the event itchy was unknown and rash was resolved on 22May2021.  The lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Fainted twice on the sidewalk within an hour and a half of shot. Ambulance was called.
w/in 1 hr began inconsolable crying +- 3-4hrs had jerking motion, eyes rolled back then less severe jerking;seen in ER: attending MD no severe problems from #1 vax
Moderna Vaccine EUA  Welt and swollen injection site, muscle aches and fatigue, nausea, bone aches
patient was given the second dose too early in the vaccine series. first dose administered on 8/16, second dose on 8/29, which was a week early.
Sore arm; Got chest pains; Headache; Chronic migrains; Pain in my neck; This is a spontaneous report from a contactable consumer or other non-HCP (patient) received via  sponsored program. A 68-years-old patient of an unspecified gender received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration on an unspecified date as dose 1, single and received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization at Baylor Dallas downtown. Patient medical history included immune system disorder and heart problems. The concomitant medication included rizatriptan benzoate (MAXALT) taken as a 10 mg for unspecified indication start and stop date were not reported. The patient experienced sore arm until the next day it went away, got chest pains, headache, pain in my neck, pain in my left arm and chronic migrains on an unspecified date. The clinical outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
all over achy & tired for 3 days. cold chills, queasy stomach, fuzy head, left arm very sore. Left arm & left foot feel very hot from the inside but normal when touched from the out side. Last few days most pain is in the neck and arm had a very bad headache. It has been 6 days since shot and I feel 85% normal.
On 1/12/22, the morning after the Moderna booster shot, I woke with a funny sensation in my left forearm. It was intermittent throughout the day and became more like a burning sensation. By Friday the 14th, it was pretty consistent and I awoke with full body aches. I scheduled a COVID test that was negative. Sunday the 16th, I was almost 100% better, but still had the burning sensation in my left forearm, mostly along the radial nerve. By Monday the 17th., I was feeling like my normal self, except for the intermittent painful burning of the left forearm.
About 10 days after her mmr vaccine she started having fevers ranging from 99.9-103.3 for about 2 days then on twelfth day after vacc we started seeing small red bumps on face and spread lightly over body, 1 day later the amount of spots has tripled and are bigger in size.  She is uncomfortable but the fevers are at least gone.
No additional AEs reported; Nurse reports the administration of MMR II intramuscularly versus subcutaneously.; Dose frequency: 0.7 mL; This spontaneous report was received from a register nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 03-AUG-2022, the patient was vaccinated with mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) (lot number W009105, that was verified to be a valid number with an expiration date reported and established as 04-DEC-2023), administered at dose 0.7 milliliters (ml) (incorrect dose administered), intramuscularly versus subcutaneously (incorrect route of product administration), with a 25 gauge (G) 5/8 inch subcutaneous needle in the deltoid region, for prophylaxis (strength and vaccination scheme were not provided). No additional adverse events were reported.
headaches - starting Jan 6th and persisting but less intense joint pain - starting Jan 6th and persisting but less intense Rash on arms, legs, thorax - erythematous, raised, vesicular in places and mildly pruritic - Jan 10 and persisting
Patient received the vaccination on 09/10/2021 and waited in the pharmacy for 10-15 minutes after the immunization and reported no adverse reaction. Patient then woke up the next morning with extreme pain in his arm that went up his neck and limited his range of motion.  The pain has decreased but is still present and remains limited in range of motion.
The following day, severe headache, extreme dizziness, achiness, joint pain, nausea, weakness, chills, soreness at injection site.  Day 2, same as day 1, less severe, except for injection site which was more tender, swollen.  Day 3, nausea and injection site swelling and tenderness continues. Treated self with rest, naproxen and heat.
Patient has history of anxiety so she was anxious even before taking the vaccine but she was fine before leaving.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 30-DEC-2015 at 02:05, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 8.4 (5 hours 57 minutes) and 5.9 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
~2wk p VAC.  Body Aches, fever painfull muscles esp Back, Legs Lasted ~ 1-2wks - Better c ADVil ANd Resolved ~ 2wks venous U/S Neg of legs Really was pretty ill - fever, myalgias NO Rhinorhea, cough, soar Throat NO GI Sx  N/V/D got COVID test VIA PCR - condition Atypical it was - Few day later seen by me (MD) NO coviD found 0 But WBC CRP SXR concerning - repeated ~ 2day & should se improvement - since was outside lots & traveled lots in horse Busniss did not want to miss I Added Doxy Doxy & Aleve seemed help repeat Las ~ 1wk Back to me But Adviced to NOT take Next Moderna VAC will look for A Johnson/Johnson Call me - Dr. for questions
weakness; pain in his left arm; stomach ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PAIN IN EXTREMITY (pain in his left arm), ABDOMINAL PAIN UPPER (stomach ache) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced ASTHENIA (weakness), PAIN IN EXTREMITY (pain in his left arm), ABDOMINAL PAIN UPPER (stomach ache) and HEADACHE (headache). On 07-Apr-2021, ASTHENIA (weakness), PAIN IN EXTREMITY (pain in his left arm), ABDOMINAL PAIN UPPER (stomach ache) and HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up received and does not contain any new information.
not feeling well; fever; threwup; Case reference number MOD-2021-036768 is a spondaneous report which refers to a Female patient.    The patients relevant medical history included Covid-19. There were no concomitant medications provided.  On unknown date, the patient first of two planned doses of mRNA-1273 (Batch # unknown) unknown location, for prophylaxis of COVID-19 infection.  .  On an unknown date, the patient experienced not feeling well, fever, and threw up. The patient went to the hospital for not feeling well and was admitted for two days. There was no treatment information provided.   The action taken for Moderna COVID-19 Vaccine was not provided.  The outcome for the reported events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient developed an erythematous area over the site of her injection after receiving pneumococcal and influenza vaccines. Area is warm to touch confluent erythematous. Was given a prescription for a 7 day course of BACTRIM.
Patient developed rash consistent with Varicella on 10/14/05.  Patient had a diffuse papular rash that was itchy.  There had been no known exposure, but the distribution made me suspicious of Varicella.  I only treated with Zyrtec for symptom relief and he did well as far as I know.
pt recv vax 5JUN97 &  6JUN pt exp swelling, redness & warmth on lt arm from site of inj to elbow;2 days post vax 7JUN pt was adm to hosp for swelling from the shoulder to wrist;pt tx w/IV ATB for poss infect & DPH for poss allerg rxn;