chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cellulitis; had an allergic reaction; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 56-year-old (reported as "I am 56") patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN), reported as "pneumonia vaccination"), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing); "SLL lymphoma" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Flu, reaction(s): "no reaction"; Shingrix, reaction(s): "no reaction". The patient also received the Flu & Shingrix vaccinations with no reaction. In fact, the patient received the Shingrix vaccination at the same location as the pneumonia vaccination.  The following information was reported: CELLULITIS (intervention required, medically significant), outcome "unknown"; HYPERSENSITIVITY (intervention required, medically significant), outcome "unknown", described as "had an allergic reaction". Clinical course: the patient had received the pneumonia vaccination on 25Mar(year unspecified). The patient thought she/he had an allergic reaction, as the patient ended up with cellulitis. This is the same reaction to the pneumonia vaccination the patient had 6-7 years ago. This is the only vaccination in which the patient get cellulitis.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: There is a reasonable possibility that the event hypersensitivity was related to PNEUMOCOCCAL 13-VAL CONJ VAC based on known drug safety profile. The association between the event cellulitis with PNEUMOCOCCAL 13-VAL CONJ VAC can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Started getting a headache within a few hours of receiving the vaccine. By 12:30am, had a severe headache, body aches, nausea, chills, vomiting and joint pain. Vomited twice and then just slightly nauseous. Severe headache/body aches and joint pain lasted about 30 hours. Nothing dangerous, but I thought you should be aware. Also, there is conflicting information about the types of pain relievers you may take. I was told nothing but tylenol by 2 physicians but the CDC says ibuprofen is OK. I only took tylenol and it did NOTHING for the pain. Sunday by about 10am (42 hours or so after vaccination) I felt 1000 times better, but still have a slight headache.
This spontaneous report received from a medical assistant concerning a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-APR-2017, the patient received an improperly stored dose of PROQUAD (dose, frequency not reported) (Lot: M043306, expiry date: 24-APR-2018) reconstituted with sterile water diluent (unknown lot number and expiration date). Temperature and Time frame: -14°C to -10°C for 9 hours 43 minutes, -14°C to -10°C for 15 hours 46 minutes, -14°C to -10°C for 12 hours 31 minutes. Previous temperature excursion was -14°C to -10°C for 6 hours 26 minutes. The call was because of data logger. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA000302: US-009507513-1705USA000847: US-009507513-1706USA000303: US-009507513-1706USA000300.
Vomiting followed by pale and brief unresponsive episode. Occurred after 2 month shots as well. About 5 hours after both. Both were precipitated by vomiting.
no known side effects; temperature excursion for VAQTA; This spontaneous report was received from a vaccine coordinator and refers to a patient of an unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 30-DEC-2021, the patient received incorrectly stored hepatitis a vaccine, inactivated (VAQTA), 1 dosage form, lot #U024505, expiration date: 15-OCT-2022, administered for prophylaxis (route of administration was not provided). No known side effects were reported.
Rec'd 15 mo shots on 6-01-16 at WCE. Developed fever 6-02-16 (101-103 max). Seizure occurred 6/02 pm while being given bath. 911-transport to local hospital. D/c' d and seen at PCN 6-03-16 for follow-up (+) induration ~ 3x3 cm. Bruising (slight) to (LT) thigh. Seizure info and supportive care discussed with parents.
RM PAIN, TEMP 100.0, CHILLS, HA, NAUSEA Narrative: RM PAIN, TEMP 100.0, CHILLS, HA, NAUSEA following 2nd COVID Pfizer vaccine causing loss of work.
Sharp shooting pain in left eye where I have a scleral buckle from a previous retinal detachment.  It started in the middle of the night while I was sleeping and lasted about 6 hours where it was accute anytime I was on my left side.  It felt like something was stuck in my eye or like I had a very bad scratch.  After the first 6 hours the pain lessened but my eye still was swollen causing headache for the next 24 hours or so.  I went to the eye doctor to have them check it on Monday afternoon about 14 hours after the pain began.  They did not find that I had a scratch or anything in my eye.  I think my eye was just swollen and pressing on my scleral buckle in a funny way.  I also had the other normal joint aches in my whole body and chills whish lasted about 18 hours and a very sore left arm at the site of the injection
Currently admitted - 11/14/21 to present 11/19/2021 ( 5 days)  PT is a 71 y.o. female known ESRD on HD who is a resident from  facility for many years presented to  emergency department for altered mental status.  Patient tested positive for COVID-19 on 11/12/21.  Patient is alert and oriented to herself.  Upon emergency department arrival, vital signs are overall stable.  Patient noted to have a cellulitis of bilateral lower extremity which patient is receiving penicillin.  Workups at emergency department, complete blood count without leukocytosis, UA with pyuria but negative nitrite, lactic acid elevated at 2.5, CMP with elevated potassium and phosphorus without EKG changes.  There is also hyponatremia.  Chest x-ray showed COVID-19 pneumonia.  During stay at emergency department patient had hypoxic event 81%, acquiring 3 L nasal cannula oxygen support.  Patient being transferred here due to need of hemodialysis.  PT is a 71 y.o.  female who is seen in consultation for a history of end-stage kidney disease. She typically dialyzes at on a MWF schedule. She uses a left forearm brachiobasilic loop graft for dialysis access, and has an estimated dry weight of 64.5 kg.  The patient was taken to the emergency department at  Hospital for altered mental status.  The patient was found to have cellulitis of her lower extremities.  Labs demonstrated elevated potassium and phosphorus and hyponatremia.  Chest x-ray was consistent with COVID-19 pneumonia, the patient had previously tested positive on 11/12.   When seen, the patient endorses chronic back pain, which is unchanged. She denies fevers, chills, nausea, emesis, headaches, visual changes, tinnitus, epistaxis, oral ulcers, sore throat, chest pain, shortness of breath at rest, dyspnea on exertion, cough, wheeze, orthopnea, paroxysmal nocturnal dyspnea, abdominal pain, diarrhea, hematochezia, melena, rash, and pruritus.
ringing in her ear,ringing specially in her left ear,ringing comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in her ear,ringing specially in her left ear,ringing comes and goes) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Blood pressure) and Cholesterol.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced TINNITUS (ringing in her ear,ringing specially in her left ear,ringing comes and goes). At the time of the report, TINNITUS (ringing in her ear,ringing specially in her left ear,ringing comes and goes) outcome was unknown.            Concomitant medications included are: blood pressure medication and cholesterol medicine. No treatment medications were reported. She has not had the ringing since about 2 weeks, it comes and goes
Redness and induration on left deltoid were vaccine was administered. Pt stated she had a slight fever day after receiving vaccine.
Admin PREVNAR 13 vaccine on 07/13/16 - (L) deltoid. Pt called 7/19 with c/o hot red mark 5" x 3" - itchy came in for eval same day - As above with c/o fatigue a day after injection - Advised ZYRTEC and to monitor.
2 days after Pfizer?s 1st Covid-19 dose, neck and chest area became progressively itchy most of the day with hives / red bumps covering lower neck and chest area when I checked it at night. Day 2: the same area remains itchy and burning at night but considerably less than the night before.
rash w/blisters-erythema @ inj site w/sl itching;ice to arm q2h for 24hrs;
Only a slightly sore deltoid until 7/8/23 when the fronts of my ankles began hurting while doing field work as part of a butterfly survey. Tiredness set in about 3 PM.  After laying down, cramps began in my feet and legs. I arose to work out the cramps.  Then overall muscle pain developed to a pain level of 6 or 7, lasting for about an hour.  Muscle weakness and tiredness continues this afternoon on 7/9/23.  I am reporting before the incident has ceased.
Upper L) arm red swollen, itchy area size of baseball. Told mom to administer BENADRYL PO and ice-pack to area.
6/19/09 at 3PM increased fussiness & strange eye movement. "Out of it" & fever started. 6/20/09 - Tired & diarrhea. 6/21/09 - "Very out of it". Limited activity & fever 103. 6/22/09 - Fever ended, but still "out of it" still w/ diarrhea. 6/24/09 - More interactive & playful, but still tired.
This case is cluster of 2 cases and is linked to case number 2013-01999 (same reporter, same events after administration of DAPTACEL and IPOL). Initial report received from a healthcare professional on 4 February 2013. A 5-year-old patient whose gender, date of birth, medical history and concomitant medications were not reported, had received a dose of DAPTACEL from Sanofi Pasteur (lot number: C4310BA, expiry date: 03-15-2015, number in series not reported) and a dose of IPOL from Sanofi Pasteur (lot number: H1354-2, expiry date 07-08-2014, number in series not reported) intramuscularly on the left thigh on an unspecified date. The patient had also received a dose of MMR (manufacturer: unknown, lot number, number in series and route of administration were not reported) and a dose of varicella (manufacturer:unknown, lot number, number in series and route of administration were not reported) on the right thigh on an unspecified date. On an unspecified date after vaccination, the patient experienced local site reactions of red, hot, induration at left thigh injection site which varied in size of redness and induration. Relevant laboratory data and corrective treatment details were not reported. The outcome of events was reported as unknown. List of documents held by sender: none.
7 years old when vaccinated  minimum recommended age is 12  FYSA:  A regulatory authority has been requested to enter all COVID vaccines into a regulatory website. The teams responsible for screening and administering vaccines to the refugees at the Mass Vax were/are all Title 10 Active Duty Military.   A regulatory authority is assisting with entering information into 2 different regulatory websites.
Pt states right after receiving injection felt like she " swallowed something and couldn't get it to move." She reported to the nurse but the nurse said she doesn't " know of that reaction" pt states that she is driving 2 hours back home and was still let go. Pt is also having a consistent cough and difficulty talking.
Pt experienced an anaphylactic reaction within 15 minutes of receiving vax. Pt required medical intervention, intubation and hospitalization in ICU.
Patient received Pfizer covid booster at about 3:20pm. At about 4 pm, patient came back to pharmacy complaining severe abdominal pain. Patient was sweating and looked pale. Patient's abdomen was tender to touch. Patient stated that after he had surgery early this year, he had about three episodes of severe stomach pain, and he was treated for H. pelori just a few weeks ago. He complained that the pain was mainly from the surgery site, which was on his belly button. He stated that he wanted to pass gas but was not willing to do so in the public. Patient's wife stated that patient had not been to bathroom for quite a while, which indicated that patient might be constipated. We laid patient on the floor and called ambulance. We stayed with patient until the paramedics showed up 20 minutes later, at about 4:20 pm. A phone call was followed up with the patient at about 8:10 pm. Patient stated that he was in the hospital and was ready to be discharged, however, the doctors could not figure out what was wrong. A phone call to patient at around 8:30 pm also confirmed that doctors in the hospital could not diagnose patient and more work needed to be done.
Approximately 5 minutes after her Janssen COVID19 vaccine the patient started coughing and felt her throat tightening.  I had her sit down and told her I was giving her an Epinephrine 0.3mg shot.  The shot was given in her left thigh and within a minute her throat cleared. I gave her a bottle of water. She said her heart was racing but it eventually slowed down.  I asked her if she wanted me to call 911, she felt it was not necessary.  Patient sat in our waiting room &  checked in on her every few minutes, her symptoms improved.  Patient was here over 45 minutes.  She wanted to go & felt fine.  I told her to call us or go to the emergency room if any problems arise.
Subsequent to receiving one dose of varicella virus vaccine live the pt was exposed to varicella in day care.  The pt experienced approximately 50 lesions beginning on his face. No fever was present.
hives around 1 am on November 23rd. Later that morning, around 9:00 am on November 23rd, I noticed a rash was also present on my neck and stomach/chest area.   doctor advised I take Allegra and Benadryl for 1 - 2 weeks.
This spontaneous case was reported by a consumer and describes the occurrence of (Fever) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included (shingles on her face 45 to 50 days after starting RINVOQ therapy). Previously administered products included for Shingles: acyclovir (was on acyclovir for ten days); for Rheumatoid arthritis: RINVOQ. Past adverse reactions to the above products included No adverse reaction with acyclovir; and Shingles with RINVOQ. Concomitant products included VARICELLA ZOSTER VACCINE (SHINGRIX) for an unknown indication.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced (Fever). At the time of the report,(Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 degrees Celsius.         Patient reported that 90 days after having shingles she got the first dose of the Shingrix vaccine along with her third Moderna COVID-19 vaccine and had a temperature of 103 degrees. She was not on RINVOQ at that time. She spoke with a physician that told her the fever was due to the COVID-19 vaccine.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Primary reporter did not have the lot number information, because the packaging was discarded.  The reporter's causality for the event pyrexia was not provided with RINVOQ(  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.
Ten days post-vax the patient developed erythema, papular eruption, fever, and Koplik spots in his mouth. Atypical measles are suspected.
Prolonged, pronounced joint pain.; On and off Pins and needles,; tingling in fingers arms legs and feet.; Sharp pains in legs and arms; Sharp pains in legs and arms; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8732) via an unspecified route of administration in the arm left on 25Mar2021 at 15:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medications. 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 25Mar2021 at 16:00, the patient experienced prolonged, pronounced joint pain, on and off pins and needles, tingling in fingers, arms, legs and feet and the patient also experienced sharp pains in legs and arms on the same day. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events prolonged, pronounced joint pain, on and off Pins and needles, tingling in fingers arms legs and feet and sharp pains in legs and arms were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Headache, Myalgia, ARM PAIN,CHILLS,LIGHT HEAD Narrative:
her glands are still swelling; she still has excessive sweating; she is bleeding so much and feels like crap/Really bad periods the worst in 30 years; Burning of ribs Feeling like they are on fire; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) intramuscular, administered in Arm Left on 29Jan2021 10:00 (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. Medical history included stress, allergies to Sulfa and Penicillin from an unknown date and unknown if ongoing. The patient was Intolerant to Codeine and Dilaudid. The patient previously took first dose of BNT162B2 on 08Jan2021 12:00 Lot Number: EL0142 for Covid-19 immunization and experienced Lymph swollen, Excess sweating, Headache and Sore. The patient experienced she is bleeding so much and feels like crap/really bad periods the worst in 30 years on 02Mar2021 02:00, burning of ribs feeling like they are on fire on 29Jan2021, her glands are still swelling on an unspecified date and she still has excessive sweating on an unspecified date. The outcome of the events was reported as Not recovered.   Information on the lot/batch number has been provided. Other information has been requested.
On 01/16/2001 the patient had the 'chicken pox' although the reporter did not know it at the time. The patient had 2 to 3 spots on her abdomen and was feeling lethargic, although she did not have a fever. The outcome of the patient's experiences were not reported. The patient sought unspecified medical attention. The reporter also reported the experiences of her son after vaccination with varicella virus vaccine live. Additional information is not expected.
This spontaneous report was received from a pharmacist via a company representative and refers to a female patient of unknown age. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On an unknown date in 2017 (reported as "within the last 2 months"), the patient was vaccinated with ZOSTAVAX, one injection, vial 19400 plaque-forming units (PFU) (exact dose and route of administration, lot # and expiration date were not reported) together with one injection of an unspecified flu quadrivalent vaccine (exact dose and route of administration, lot # and expiration date were not reported). On an unknown date in 2017, after receiving both vaccinations, the patient felt run-down, tired and very sick for an unspecified amount of time. The outcome of the events was unknown. The relatedness between the events and the suspect therapies was not assessed by the reporter.
Immediately following the vaccine: Headache (lasted <24 hours) treated with Tylenol. Within 2 hours of receiving vaccine: Sore muscle at the sight of the vaccine (lasted for 3 days after vaccination). 11 days after receiving vaccine: Rash about 4 inches in diameter located over the bicep on the same arm (lasted 24 hours).
I?m having real bad muscle aches. I can barely walk and I?m in a lot of  pain when I do walk.
patient  had two vaccine in same arm (left) on 09/19/22 and came to the pharmacy 09/26/22 complaining  from a rash on the left arm since vaccines administration, patient stated it was itchy and was swelled before. patient instructed to take some banadryl and will follow up with her doctor
circular area of erythematous papules & vesicules;appeared to be herpes zoster;
ACHE; LIGHT HEADEDNESS; FATIGUE; This spontaneous report received from a physician concerned a male of unspecified age. The patient's weight, height, and medical history were not 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. The company is unable to perform follow up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, the subject experienced ache, light headedness, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ache, fatigue and light headedness was not reported. This report was non-serious.
Hives on left arm several inches from vaccination site and one hive present on left thigh - patient unable to wait the 15 minutes, sx occurred 5 minutes post vaccination. Itching occurring on left arm and thigh and chest. No respiratory or cardiac symptoms. Self-administered Claritin after sx occurred.