chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lymphedema, left leg.  Pain and some swelling first noticed around 1/10/2022. On 1/13/2022 and both feet swelled up on the plane, despite wearing 20-30mmhg compression socks. Right foot swelling went away within 2 days of flight, left foot remained swollen. I flew home on 1/22/22 and again both swelled up on the plane, I wore 20-30mmhg compression socks, and again tight foot swelling went away within 2 days of flight, left foot remained swollen. I used compression bandages at home, with some small improvement, but swelling didn't fully resolve.  First reported to Doctor on 2/25/2022 after noticing pitting edema was consistent and there was a change in color in my lower left leg. Was referred to a specialist on 3/15/2022- specialist ordered 2 ultrasounds and one CT scan, which ruled out DVT, Tumors/masses in abdomen, May Thurner Syndrome, and Venous Insufficiency.  Was referred for Lymphatic therapy, which has improved the symptoms but constant compression socks, MLT, and Kinesio tape needed to minimize symptoms/swelling.
Left deltoid area - red with edema and hear 10 cm. Ice and OTC Benadryl cream.
Significant angioedema noticed 2 days after immunisation given -> unsure if VARIVAX or BOOSTRIX was the cause.  Tx with BENADRYL.
Ramped up tinnitus 24 dB ( +4 above threshold of 20 dBHL) Shrinking sensation (Depth perception?)
Left shoulder pain and limited range of motion. Pain severe, affecting sleep. Worsening since vaccination. Symptoms ongoing. Now have adhesive capsulitis.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 4-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
Loss of energy, dizziness, unable to stand or sit up for long period of time, vision becomes blurry, ears began ringing and will faint. Unable to attend school for over a month. Currently on a 14 day heart monitor.
Welt size of golf ball, painful to move or touch arm, bruising 24hours after vaccine. Cleared up in couple days. 9 days after vaccine arm became hot, softball size rash now spreading around arm of injection site. Itchy, hot, and red.  Has not received medical attention yet.
- severe chills - lasted about 4 hrs - severe headache - lasted about 24hs - body ache - joint pain - nausea - lasted about 18hrs
This medically confirmed spontaneous report (initial receipt 28-Oct-2014) concerns a 51 year old female patient. On 26-Oct-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-Oct-2014, the patient received temperature excursioned AFLURIA, (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
The pt states that she "had itching and redness all over my body. My left eye was swollen almost shut. I became hoarse and had trouble swallowing. This stated at about 7:10am on Friday, April 26th. The doctor administered Decodron 4 mg IM and Benadryl 25 mg PO."
Diagnosed with Cutaneous Mucor Mycosis at injection site by biopsy Narrative: Pt. had to have a port-a-cath placed to receive at least 2 weeks of anti-fungal medication treatment. He has not yet been hospitalized but there is potential for that to occur.
Patient received casirivimab instead of intended COVID vaccine.  At 48-hour follow up, patient reported Soreness to arm, fever of 99.9 and high blood pressure.  Wife thought he was anxious.  Follow up 2 hrs later and next morning, he reported he was "fine". Received COVID vaccine on December 31
11 x 11 cm area of swelling, erythema, induration over right thigh.
This case was reported by a consumer via out of hour services and described the occurrence of dysgeusia in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included fibromyalgia. Concurrent medical conditions included temporomandibular joint syndrome, macular degeneration and bursitis. On 13th September 2018, the patient received the 1st dose of SHINGRIX. On 13th September 2018, immediately after receiving SHINGRIX, the patient experienced dysgeusia. In September 2018, the patient experienced eye pruritus, ear pruritus, pruritus facial, swollen joints, general body pain, itchy rash, periorbital pain, generalized pruritus and unable to walk. On an unknown date, the patient experienced muscle pain and throat tightness. The patient was treated with methylprednisolone (Medrol). On an unknown date, the outcome of the dysgeusia, swollen joints, periorbital pain and unable to walk were recovered/resolved and the outcome of the eye pruritus, ear pruritus, pruritus facial, throat tightness, itchy rash and generalized pruritus were not recovered/not resolved and the outcome of the muscle pain was unknown and the outcome of the general body pain was recovering/resolving. It was unknown if the reporter considered the dysgeusia, eye pruritus, ear pruritus, pruritus facial, muscle pain, throat tightness, swollen joints, general body pain, itchy rash, periorbital pain, generalized pruritus and unable to walk to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Shortly after receiving SHINGRIX, the patient experienced a bad taste in her mouth. The patient later felt pain around her eyes, but thought it was due to allergies and/or temporomandibular joint syndrome (TMJ) and the pain would come and go. A few days after the receiving SHINGRIX, the patient noticed itching in her eyes, ears, chin and neck. She also had pains all over her body, but she had a history of fibromyalgia. About 1.5-2 weeks after the receiving SHINGRIX, the patient noticed 6 spots on her leg that she thought were bites at first that itched. The itching then went all over her body, so she thought those spots were a rash instead. The patient had an incident where the joint around her big toe suddenly swelled up and became so painful that she could not walk. Those were resolved at the reporting time. The itching and the rash have persisted and the patient started a Medrol pack day before reporting.
Itchy tongue/throat, redness of neck and chest 10mg zyrtec given, sx resolved
Visible swollen area under armpit (axilla).  Larger than single lymph node. Pain currently 2-3/10.   Also, beginning day 2 (Saturday 0800), 3 flat red areas just below injection site on anterior dorsal medial side of left arm.
1st  and 2nd day pressure headache & a bit foggy then aches in neck and shoulders.  3rd day severe abdominal cramps, bloating,  gas, fatigue.  4th day severe abdominal cramps, bloating, gas, temperature 100.9, headache, fatigue.  5th day abdominal cramps (not as severe), fatigue, low fever.  6th day  fatigue, slight abdominal cramps, occasional diarrhea.  Hoping my 7th day I will be back to normal.  The severe abdominal cramps were the worst I have ever experienced, if I wasn't 64, I would of thought I was delivering a baby, it was horrendous.
Information has been received from a nurse through a Merck pregnancy registry concerning a 25 year old caucasian female with endometriosis who on 26-Mar-2007 was vaccinated IM in the right deltoid with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #655503/0012U).  Concomitant therapy included folic acid and unspecified prenatal vitamins.  On 11-Jun-2007 the patient was vaccinated IM in the left deltoid with a second dose (lot #657737/0522U).  The patient now is pregnant.  The patient's LMP was 18-Jun-2007.  Her estimated delivery date is 25-Mar-2008.  The patient will be in the office on 07-Aug-2007.  Follow-up information received indicates that the patient had ultrasound testing on 09-Aug-2007 and 22-Oct-2007, results of both were reported to be within normal limits.  Follow up information received on 02-Jan-2008, indicated that on 28-Dec-2007, the patient had a fetal death/stillbirth, weeks from LMP 27.  Autopsy being done.  No other information available.  Upon internal review fetal death/stillbirth considered to be an other important medical event.
10.5 x 10.5cm immunization site reaction. Child had 12-72 hours ago developed erythema, heat, swelling and pain on palpation to left deltoid region. The erythema regressed yesterday. Plan to treat with BENADRYL and PO KEFLEX. Follow up 48 hrs or sooner if worsening.
upper right arm is hurting really bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (upper right arm is hurting really bad) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (upper right arm is hurting really bad). At the time of the report, PAIN IN EXTREMITY (upper right arm is hurting really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were reported. Patient is not on any Concomitant medication.
Breakthrough case admission after 4 vaccines Pfizer 1/25/21 lot# EL9261;  Pfizer 2/5/21 lot# EL9267;  Pfizer 8/27/21 lot# EW0173; Pfizer 4/16/22 lot# FJ9943
I experienced great pain in my head and at approx. 7:55, I awoke after fainting/passing out; I experienced great pain in my head and at approx. 7:55, I awoke after fainting/passing out; I experienced great pain in my head and at approx. 7:55, I awoke after fainting/passing out; experienced severe flu like symptoms all day; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 58-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0178), via an unspecified route of administration in arm right on 25Jun2021 at 15:00 (at the age of 58-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Known allergies and medical history was provided as yes (no other detail provided). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0186), via an unspecified route of administration in arm right on 04Jun2021 at 14:15 as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was provided as yes. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient reported on 26Jun2021, she experienced severe flu like symptoms all day. On 27Jun2021 at approx. 7:30 am, while sitting at desk, she experienced great pain in her head and at approx. 7:55, she awoke after fainting/passing out. Patient was alone at home at the time. Throughout that day, she experienced 4 more of these events, but none caused her to lose consciousness. Seriousness was provided as no. The patient did not receive any treatment for the adverse events. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The outcome of the events was unknown.
Developed sores on the left side of the tongue and one on my lip.; Developed sores on the left side of the tongue and one on my lip.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Sep2022 at 15:45 as dose 4 (booster), single (Lot number: GH9694) at the age of 47 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1 MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (Dose: 2 MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (Dose: 3 ( 1 st Booster)  MANUFACTURER UNKNOWN), for Covid-19 immunization.  The following information was reported: STOMATITIS (non-serious), CHEILITIS (non-serious) all with onset 09Sep2022 at 14:00, outcome "not recovered" and all described as "Developed sores on the left side of the tongue and one on my lip.". Therapeutic measures were not taken as a result of stomatitis, cheilitis.  Additional information: Patient developed sores on the left side of the tongue and one on my lip. Patient did not receive other vaccine in four weeks. Patient did not receive any treatment for the events. Patient did not have covid prior vaccination or covid tested post vaccination. Patient had no known allergies.
12 years ago her mother had facial neuritis and her symptoms are similar to what she experienced then; 12 years ago her mother had facial neuritis and her symptoms are similar to what she experienced then; back of both hands and ears,  jaw line, front of elbows both arms very uncomfortable; back of both hands and ears,  jaw line, front of elbows both arms very uncomfortable; back of both hands and ears,  jaw line, front of elbows both arms very uncomfortable; back of both hands and ears,  jaw line, front of elbows both arms very uncomfortable; three fingers of both hands from thumb to middle finger with numbness,half of index finger on right hand with numbness; both temples and upper lips feels uncomfortable; both temples and upper lips feels uncomfortable; stuffy nose; injection site uncomfortable along the nerves; injection site uncomfortable along the nerves; This is a spontaneous report from a contactable consumer (patient's daughter). A 66-year-old female patient received BNT162B2, dose 2 via an unspecified route of administration, administered in Arm Left on 20Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included facial neuritis from 2009 (12 years ago her mother had facial neuritis and her symptoms are similar to what she experienced then), breast cancer from 2014 (states 7 years ago her mother had breast cancer), nerves were hurt after treatment of cancer. The patient's concomitant medications were not reported. The patient previously received BNT162B2, dose 1 via an unspecified route of administration, administered in Arm Left on 23Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization and experienced 'both elbows were uncomfortable'. The patient's daughter stated her mother (the patient) received the second dose of the vaccine on 20Feb2021 in her left arm. Side effects were stronger this time and were on the back of both hands and ears,  jaw line, front of elbows both arms very uncomfortable, three fingers of both hands from thumb to middle finger with numbness, half of index finger on right hand with numbness, both temples and upper lips feels uncomfortable. Her mother also has a stuffy nose and injection site uncomfortable along the nerves. Twelve (12) years ago her mother had facial neuritis and her symptoms are similar to what she experienced then. Her grandmother (patient's mother) had strokes in the past and she just wanted to share that family history in relation to nerves. Patient's daughter states 7 years ago her mother had breast cancer and her nerves were hurt after treatment of cancer and she went to the hospital and the doctor said everything was okay no problems and she never had problems after having facial neuritis. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
This spontaneous report was received from a pharmacist referring an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 12-JAN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX, with expiration date 26-DEC-2016, for prophylaxis (dose, route and lot # were not reported). No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
longer than recommended dosing interval; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in 2019).   On 27th July 2021, the patient received the 2nd dose of Shingrix. On 27th July 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix in the left deltoid at later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Client stated via telephone that after leaving the center he became nauseated with 3 episodes of vomiting. He also c/o a severe headache.
severe rash/worsened considerably; severe itching; dizziness; swollen tongue; tight throat; even bothering my eyes; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 18Feb2021 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included rheumatoid arthritis, neuropathy, heart disease, starts and stop date was not reported for all and patient was allergic with sulfa. The patient's concomitant medication(s) included prednisone; gabapentine and unspecified blood pressure medicine, all are taken within two weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 78-year-old at the time of vaccination), via an unspecified route of administration in left arm on 25Jan2021 at 03:00 pm as a single dose for COVID-19 immunisation. Patient previously took simvastatin and had allergies. On 24Feb2021 at 12:00, the patient experienced severe rash and worsened considerably, severe itching, dizziness, swollen tongue, tight throat, even bothering my eyes. Patient received treatment with benadryl then Zyrtec for all events. Patient not received other vaccine in four weeks of vaccination. Patient visited doctor office/clinic visit for the events. Patient had not covid prior vaccination and not tested covid post vaccination. The final outcome of all events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
right after the vaccination i had severe headaches and then severe chest pains. I am tired all the time and the doctor doesn't seem to find anything
fever/low grade fever; Headache; This is a spontaneous report from a Pfizer Sponsored Program  via a contactable nurse (patient). A 44-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EV1685) via an unspecified route of administration in right deltoid on 13Jan2021 14:30 at single dose for COVID-19 immunisation. She received her first dose of BNT162B2 on 23Dec2020 13:30 (at age of 44 years old) for COVID-19 immunisation. There was no medical history. The patient's concomitant medications were not reported. The patient received the second dose of her Pfizer vaccine on 13Jan2021. She has a headache and fever (on Jan2021), which lasted a whole week. She still had a headache and a low grade fever and today is day 8th. Inquiring if that is a normal side effect, with the vaccine is it common or how long should she expect this. She received Advil and Tylenol as treatment. She had COVID test yesterday (20Jan2021) it was negative. Relatedness of drug to events headache and fever was reported as related by reporter because she had them since the second dose. Events outcome was not recovered.
Pt vaccinated 5/12/12 (ZOSTAVAX), on 5/14/12 she came in with area red, swollen, and irritated at shot site. Pt already takes ALEVE, I told her to report it to her PCP, to use a cold pack, and let me know if it get worse - no other sx reported.
I felt extra tired before bed that night. I woke up at 06:30 I had some body aches and felt really fatigued and had some nausea. I felt well enough to work from home. I logged on and worked but by 08:30 am - I had a fever 101.6. I did take two Tylenol 325mgs at 09:00 am. I kept on with chills and fever and it went down  to 99.6 and it bounced back up in afternoon and I took another dose of Tylenol (325 mgs each) - at 1:30 because it was up for 101.6 - with nausea, chills and body aches. Tylenol did help again this time. I didn't take my temp after work. Right before bed, the chills had basically gone away but I took another dose of Tylenol (two of the 325 mgs) before bed. I woke up the next morning feeling really well with just a little a bit of fatigue (so I was 95% back to normal).
Large 17 x 15 inch area of erythema warmth and pruritus and swelling. Treated with Claritin and oatmeal.