chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On Friday, 10/09/09, I was called and told patient had a severe headache that started soon after her flu vaccine was given the day before.  On Friday, she described the headache to be so bad she "could not think straight and it felt like a band was across her head."  At this time she was advised to see her doctor for treatment and advise.  On 10/13/2009, patient reports, "Within 20 min. of the shot I had a headache, then in one hour had malaise, body ache, trouble concentrating, plus redness, swelling and soreness at the injection site.  They progressed to the next day.  The headache became less thru the day, but the rest stayed constant into the evening.  Sat. a.m. most of the symptoms were gone. The injection site was still sore, mildly red, but swelling gone.  By Sunday all symptoms were gone. No treatment was sought."
TOOK TWO DOSES IN A ROW; This spontaneous case report was received from a consumer (PVX2019-071) on 08-Jan-2019. The report describes a 67-year-old elderly male consumer who "took two doses in a row". The consumer was receiving oral Vivotif (one dose every other day) for typhoid prevention.  It was reported that the consumer took the first two doses of Vivotif on 07-Jan-2019 and 08-Jan-2019, respectively.  The action taken with Vivotif with respect to the event "took two doses in a row" was not applicable.  The clinical outcome of the event "took two doses in a row" was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.
Prevnar administered left thigh. during evening hours, child felt warm, temperature not taken, drowsy, slept for 3 hours, then started vomiting, vomited 6 times.  Next AM 07/28, afebrile, normal activity, taking fluids.  Local site with redness no warmth.
Client called nurse on 06-01-04 to report problems occurring begining 05-25-04 PM after being vaccinated with Td and Twinrik.  Reported headache, light headed feeling with elev. temp.  05-25-04 PM took ibuprofen. 05-26-04 continued to have headache with light headed feeling grad. temp elev. to 103.5 by 05-26-04 PM went to ER, pt. received IV fluids for dehydration and pain meds for headache. 05-27-04 grad improved by 05-28-04 felt much better, low grade temp. cont.  Did not want medical records sent to health dept.
Pt was not to get a Pediarix.  Pt should have only received the Dtap instead of Pediarix
Describes injection site soreness, discomfort in hand & shoulder (L) staring 2 hours after injection - went to ED. Next day increasing discomfort & swelling of (L) hand. 6 days later reported to me - (L) hand still swollen - describes shooting pain (occasional) in both arms & legs (reaction) again went to ED - Neurologist referral.
Fever (16 hours),  body aches (13 hours), tired  Took Tylenol to help relieve the fever and body aches.
Itchy skin; rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy skin) and RASH (rash) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History Information was reported.     On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PRURITUS (Itchy skin) and RASH (rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash pruritic, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchy skin) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included high blood pressure and cholesterol medications.
Patient states she experienced swelling, redness and pain at site of injection starting that evening.  By the following morning swelling had gone away however redness and pain remained.
Sore arm at first  - this was normal, with localized swelling.  However the swelling never went away, but became a lump and what is con erning is that I noticed in the last several days that the lump is hot to the touch.  I had not looked at it in the mirror so I don't know how long it has been red, but the lump is red exactly where it is hot.  I have been unable to find any information about side effects including hot, swollen, red injection sites more than a week after the shot, so I am reporting it.  My doctor is not pro-vaccine (!) so I am not taking this to her.   This may be nothing but I hope this does not mean some kind of allergic reaction.  I still plan to get dose #2.
Local reaction-diffuse erythema, warmth, and edema of upper arm (greater than 14cm, long and circumferential) Treatment: ice, Zyrtec, Advil.
PATIENT STATES THAT THEY HAD LOWER BACK PAIN, JOINT PAIN ALL OVER THE BODY.  JOINT PAIN AND LOWER BACK HAS GOTTEN BETTER BUT SOMETIMES HAS A KNEE TO ANKLE SHOOTING PAIN ON THE LEFT LEG.
She had shortness of breath and rash.  Resolved on it's own without mediation .
Procedures - documented in this encounter Procedure Name Priority Date/Time Associated Diagnosis Comments OUTPATIENT ONLY SARS COV 2 RNA, RT PCR Routine 04/06/2021 4:40 PM  Flu-like symptoms
Woke up on 4/14/21 with extreme nausea, but could not throw out.  Headache all day, slight fever, pain at needle sight (left arm), diarrhea, extreme lethargic feeling.  Could not eat anything all day due to the bloated feeling.  Had taken Tylenol the night of the vaccine.  This was the second dose.  I had no reactions for the first dose.  Took Tylenol again in the evening and put ice on the arm and this seemed to alleviate the headache and pain somewhat.  I slept a lot.  It is 5:27 p.m. now and I am starting to feel a little better.
Pt received the vaccine between 4 to 5pm on 5/1/2019 and noticed  a red raised patch on her left arm (below the injection site to the area above the elbow). Pt came to the pharmacy around 11:45 am on 5/2/2019 to report the adverse event. The patch was hard and warm. Pt didn't have any fever or didn't feel itchiness on the area around the injected site.
Muscle weakness; tired; Feeling hot; eyeball pain; Headache; Caller is the patient that received one dose of the Moderna Covid vaccine on 20 Jan 2021. Yesterday he received the Pfizer Biontech covid 19 vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer sponsored program support. A 61-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0198, expiry date: not reported) via an unspecified route of administration, administered in Arm Left, on 30Jun2021 at 15:00 ( at the age of 61 years), as 0.3 ML single for covid-19 immunisation. The patient received covid-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE, Batch/Lot Number: 027L20A), via an unspecified route of administration, on 20Jan2021 at standard dose, in left arm, for covid-19 immunisation and had a bad reaction to it. The patient medical history and concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Prior vaccination (within 4 weeks) was reported as the patient had shingles vaccine about a month ago. Family Medical History Relevant to AE was reported as no. On an unspecified date, the patient had experienced muscle weakness, tired, feeling hot, eyeball pain, headache. Reported feeling a little bit of eyeball pain, not bad and a little bit of a headache. The symptoms started the night before the day of reporting and most of the effects were on that night and on the morning of reporting. Stated his cup of coffee made him really hot. Side effects were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Adverse events did not require visit to emergency room or physician office. The outcome of the event headache was reported as recovered. The outcome of other events was unknown.
Patient reports left sided facial swelling in lower left mandibular area, 3 weeks post 1st vaccine dose.  Swelling was paired with small vesicular sores/rash on face and under chin, mainly on left side.  These events followed by scattered itchy sores on lower body.  MIddle section, streaky red marks.  Welts and bumps on upper back, heels, ankles- very itchy.
pain at the injection site; myalgia; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in 2019, refer case US2021047797).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain and myalgia. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and myalgia were recovered/resolved.   It was unknown if the reporter considered the injection site pain and myalgia to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient herself. The age at vaccination was not reported, but it could eb 53 or 54 years. The patient stated that within 3 hours of receiving dose 2, she experienced left arm pain at the injection site that resolved after 3 days.  She stated experiencing myalgia 1 day after her dose that lasted for 3 days and resolved. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021047797:same patient, same reporter, 1st dose
Patient received 2nd monovalent pfizer vaccine the morning that monovalent vaccines were no longer authorized to use. This information was received by staff after administration.
Approximately 25 minutes after receiving the vaccine, pt. started c/o headache.  Upon assessment, pt. appeared to be weak and lethargic.  BP: 130/74, HR: 42, RR: 16, O2 sats: 93-98%.  No other symptoms noted at this time. Local EMS was called for assessment.  Pt. and daughter decline taking patient to emergency room, but is going to make an appt. with PCP at this time.
Fever will Chills and full body ache Taking ibuprofen or acitaminofen every 4 hrs
01/26/2022: In the evening I started having a little bit of problems breathing. The next morning I was still experiencing the problems breathing and I was feeling fatigue. I went to urgent care to get tested for COVID on 01/27/2022. I received my results on 01/30/2022 and it showed I was positive for COVID. 02/07/2022 I had a tele visit and my doctor ordered x-rays and the result was positive for pneumonia. They prescribed albuterol, azithromycin and prednisone. On 02/14/2022 I was having problems breathing, I had a resting heartrate of 124 and experiencing chest pains so I went to emergency room. They did a CT Scan and the doctor said he didn't see much pneumonia in my lungs and I was sent home.  He also told me that I had long COVID symptoms. I still experience brain fog. For example I get up to get a banana and by the time I get to the kitchen I forget what I went in there for.
Stomach pain, nausea, headache (so far). (Maybe it's something else).
DIARRHEA, LIPS AND TONGUE TINGLING. SHE WOKE UP AT 2AM AND FAINTED FOR 30 SECONDS. HUSBAND APPLIED COLD COMPRESSES TO HEAD AND ARM DUE TO REDNESS AND SWELLING OF RIGHT ARM.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnicity. 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) 1 total dose administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient was vaccinated in April and got sick with covid-19 infection in AUG-2021, the patient experienced suspected covid-19 infection and had suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority:90000191148 This case, from the same reporter is linked to 20210855235 and 20210855254.; Sender's Comments: V0 - 20210854979- covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient received dose of Pfizer COVID vaccine on 04/20/21.  He received a dose of Moderna COVID vaccine on 05/09/21 instead of the Pfizer .
Information has been received from a registered nurse concerning an 18 week old male patient with a history of premature birth at 28 weeks who on 17-MAY-2010 was vaccinated with a dose of ROTATEQ; he did not receive the first dose while in the hospital. On 21-JUL-2010 the patient was vaccinated with a second dose of ROTATEQ. No adverse symptoms were noted. Additional information has been requested.
Chills shaking, pal, Short of breath, later vomiting. Next day muscle aches, fatigue.
After receiving shot, patient became very light-headed and dizzy. She actually lost consciousness for a few seconds. Paramedics were called and her blood pressure was 74/49. They took her to the hospital and gave IV fluids. Her blood pressure stabilized and she was sent home.
Had fever on 10-19-13 in AM. Swelling to left thigh. Increased thigh circumference. Itchy.
Initial report received from a health care professional on 15 September 2014. An 80-year-old female patient, with no reported medical history or concomitant medications, received an intramuscular left deltoid injection of FLUZONE HIGH DOSE (lot number U5042AA) on 12 September 2014. That same evening, she presented to the emergency department with swelling and redness around the vaccination site. She was diagnosed with cellulitis and treated with Cephalexin. As of 15 September 2014, the area was "much better" and only slightly red. No information regarding laboratory testing was reported, and the patient had not yet recovered at the time of the report. Documents held by sender: None.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient.  No information was provided regarding medical history, concurrent conditions, or concomitant medications.  The patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions.  On or about 23-OCT-2013 (patient was 60 years old at this time), the patient was administered zoster vaccine live (ZOSTAVAX) by a pharmacist at a pharmacy (dose, route, and lot # not provided).  On an unspecified date, the patient was treated by a physician for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster.  The outcome of the event was unknown.  Additional information has been requested.
Small bump from deep in the tissue at the injection site began rising to the top, and eventually became a raised pink bump at the surface, which had pus in it.  I believe this would be classified as an injection site abscess?   Please note, the pharmacist cleansed the site appropriately & I don?t believe this has anything to do with injection technique.  The site looked perfect for at least a week or more, it didn?t behave like an infectious process.  There was never any redness, warmth, increased pain, etc? until the bump finally surfaced- when I pressed on it and finally? I ?popped? and cleaned it.   (Sorry, I know I should have let a doctor).  Currently it has a scab and is sore like a bruise.
Got the vaccine, had no reactions.  Then about 4 days later he was going for a 2 mile walk and started out on the walk and had not done a 1/4 of a mile and he started to feel warm.  He had pain in his trapezius muscles into his neck, had a headache and had a bad pain in the pit of his stomach, joint pain in his knees and started to get vasovagal event, everything looked bright and the white things seemed to glow.  He then walked back to his vehicle slowly.  Since then every time he does anything exertionally, walking for any short distance the same symptoms seem to come on.  He also has a tired feeling.  He called his cardiologist and he suggested that he should try drinking a lot of water to hydrate himself.  His brother-in-law is a paramedic who also told him to hydrate before his vaccine.   He's been drinking a lot of water.  He does have a stomach issue, and has been having the nausea but believes that was preexistent to the vaccine.  He has not had any reactions around the injection site itself.  He did have some soreness in the arm for a couple of days initially, but had also gotten a regular flu vaccine through the hospital and had the same reaction with that.
This case was reported by a consumer via call center representative and described the occurrence of tingling feet/hands ina 48-year-old female patient who received FLUARIX QUADRIVALENT (batch number 7HR72, expiry date 30th June 2016). Concomitant products included magnesium, vitamin C, Curcumin and fish oil. On 22nd October 2015, the patient received FLUARIX QUADRIVALENT .5 ml. On 22nd October 2015, several hours after receiving FLUARIX QUADRIVALENT, the patient experienced tingling feet/hands and numbness of extremities. On 26th October 2015, the patient experienced tingling lips and numb lips. The patient was treated with ZYRTEC. On an unknown date, the outcome of the tingling feet/hands and numbness of extremities were not recovered/not resolved and the outcome of the tingling lips and numb lips were unknown. The reporter considered the tingling feet/hands, numbness of extremities, tingling lips and numb lips to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: This case was previously reported to manufacturer. The patient stated that she had never taken any medication. On 22nd October 2015, between 1 pm to 2 pm, the patient received a dose of FLUARIX QUADRIVALENT. On 22nd October 2015, early evening, the patient started to experience bilateral transient tingling and numbness in her hands and feet. Over the weekend (24th October 2015 to 25th October 2015), minimum 2 days after vaccination, the patient experienced tingling that went up to calves. On 26th October 2015 (Monday), in morning, 4 days after the vaccination, the patient woke up with transient tingling and numbness in her lips, tongue and the tip of nose, which was very noticeable. The reporter stated that, she contacted to nurse because she could be having a stroke but she did not think that was a stroke. At the time of reporting, the patient did not diagnosed with stroke. The patient was told to ZYRTEC and to contact her health care professional the next day. The patient visited the doctor and was informed that the events were due to FLUARIX QUADRIVALENT. On 30th October 2015, the events were got worsened. The patient tried to contact her physician but the physician was not available. The reporter stated that, FLUARIX vaccine was mandatory for her to keep her job.
frightened about taking the second dose; worsened gastritis; doubled up on medication; severe chest pain on left side; Chills; left rib cage is killing her and around her kidney; has not been eating; This is a spontaneous report from a contactable consumer. A 73-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administrated in left arm on 24Feb2021 01:00 (age at the time of vaccination 73-years-old), as a single dose for COVID-19 immunization. The patient's medical history included breast cancer, she had breast cancer in 2014 or 2015, the nodes were removed, she was on an antibiotic when she had cancer, and surgeries. The patient's concomitant medication included Nexium 20mg daily for a hiatal hernia and acid reflux and it works. On 24Feb2021, the patient experienced worsened gastritis, doubled up on medication, severe chest pain on left side, Chills, left rib cage is killing her and around her kidney, has not been eating; and on an Unspecified date frightened about taking the second dose. On an unspecified date, the patient underwent lab tests and procedures which included Blood pressure measurement: normal; and Chest X-ray: unknown results, she had a Chest X-ray two years. The outcome for all the events was not recovered and frightened about taking the second dose was unknown.  No follow attempts are possible. No further information is expected.
Pain and inflammation with warm area at injection site; site is 4" x 4" red, patient has taken TYLENOL, ice, and lavender oil.
STRANGE SIDE EFFECTS; ACHEY; SORE ARM; TIRED; This spontaneous report received from a patient concerned a 68 year old female. 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 expiry date: UNKNOWN) dose was not reported, administered on 17-MAR-2021 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 MAR-2021, the subject experienced strange side effects. On MAR-2021, the subject experienced achey. On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, achey, strange side effects and tired was not reported. This report was non-serious.
AREA OF INJECTION STARTED AS RED, RAISED AREA ABOUT 3cm. ON 10/25/12 THE RED, RAISED AREA HAD INCREASED TO ABOUT 3" IN DIAMETER. THE AREA WAS HOT TO TOUCH AND TENDER. NO RED STREAKS, PATIENT REMAINED AFEBRILE.
insomnia, bloating, headaches, fatigue, body aches, muscle aches, muscle cramping, pain at injection site, arm pain, low energy, constantly tired, joint pain, this has been going on for two weeks now
Patient developed shingles-in right upper thigh. June 20th 2010 Herpes
Pt recv vax on 10/27/98; on same day pt exp Rt arm swollen, hot, painful w/ blisters
Low grade fever and headache. Startin on day two redness, warmth, and itching at injection site. Growing erythema  at the injection site.  C/o swelling and pain at site. As of today (02/09/2021) erythema is about 70 mm.
18 year old patient was administered a dose of PROQUAD; This spontaneous report was received from a nurse regarding an 18 year old patient of unknown gender. The patient's concurrent condition, pertinent medical history, concomitant therapies and drug reactions/allergies were unknown. On an unknown date in November 2019 (reported as last week), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose, anatomical location, lot # and expiration date were unknown) taken subcutaneously for prophylaxis (product administered to patient of inappropriate age).
Client states that one day after her first Moderna COVID vaccine on 1/30/21 she experienced pain and decreased movement in the arm where she got her shot.  One day after her second Moderna COVID vaccine on 3/4/21 she again experienced pain and decreased movement on the other arm where she got her shot.