chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 56 year old female patient reporting on herself. The patient had no concurrent conditions or pertinent medical history. The patient's or concomitant medication included aspirin (manufacturer unknown) and losartan potassium (manufacturer unknown). On 23-SEP-2017, the patient was vaccinated with ZOSTAVAX for preventing shingles (dose, route of administration, lot number and expiration date were not reported). On an unspecified date in September 2017, after the administration of ZOSTAVAX the patient experienced injection site redness and it was hard. She had a tingle on the left side of her face and it was also swollen. She also said that her left side intestines were swollen (abdominal distension). She was taking acetaminophen (TYLENOL) and Ibuprofen for the pain. Also her body felt weak like she was about to have a fever (asthenia). The patient reported that no lab diagnostics/studies were performed and she did not sought medical attention. The outcome of injection site erythema, paraesthesia, pain, abdominal distension, swelling face, asthenia and injection site induration was reported as not resolved. The causal relationship between the aforementioned events and therapy with ZOSTAVAX was not reported.
I woke up between 1 and 2 am. I had chills and every joint in my body hurt. I had to go to the bathroom. I had nausea, chills, vomiting until the next day around 6pm. My legs started feeling weak, I got hot, I started to go up the stairs and felt like I was going to pass out once I got to the middle of the stairs. Next thing I know, I am at the top of the stairs laying down. My migraines were out of control and my medication could not quell them. By Sunday, the chills start to subside but I now have diarrhea. On Monday, I tried to go to work and started to feel as if I was going to pass out again. I got off the turnpike and went to the Urgent care. I was given Zofran for the nausea. Urgent care told me it could take 3 to 4 days for me to feel better.
This spontaneous report was received from a medical assistant and refers to a 13 months old female patient. No information regarding the patient's pertinent medical history, concurrent conditions and drug reactions/allergies was provided. On 04-AUG-2016 08:53 am, the patient was vaccinated with an improperly stored first dose of M-M-R II (rHA) lot # L030162 (expiration date and dose were not reported), via subcutaneous in unspecified thigh. It was reported that the vaccine was exposed to a temperature excursion described as a minimum (MIN) of 33 Fahrenheit (F) degrees for 10 minutes and a maximum (MAX) of 48 F degrees for 10 minutes. The healthcare worker also stated that the MIN and MAX were not cleared previously. No previous temperature excursion was noted. Patient's concomitant medication was not provided. No adverse effects were reported. A product quality complaint was not involved. This is one of the several reports received from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Case number PHEH2013US013250, is an initial spontaneous report received from a nurse on 14 Jun 2013, and with a follow up report received from nurse on 09 Jul 2013. This case refers to an 18-year-old female patient. Her medical history and concomitant medication were not provided. She was vaccinated with MENVEO, (batch number: M11082 and expiry date: 31 may 2014), at a dose of 0.5 ml intramuscularly into left deltoid on 13 Jun 2013. Reporter stated that, un-reconstituted MENVEO reached -1 degree Celsius for at least 30-minutes before going back up to 6 degree Celsius on 07 Jun 2013 (vaccine did not freeze). No adverse event was reported following this administration error. Follow up report received from nurse on 09 Jul 2013. Updated patient demographics, site of vaccination and date of vaccination.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Mild, Systemic: Weakness-Mild
Client received her second dose of Moderna lot #: 017C21A exp. 5.23.21. The client removed her mask while sitting in the observation area following vaccination. EMTs responded. The client reported she ?is having a little breathing issue?. EMT took client's vitals: blood pressure 162/95, oxygen saturation 97%, heart rate 76, and respiration 18. Client disclosed she has high blood pressure and did not take her blood pressure medication today. Co-lead RN assisted EMTs with assessing client. Client states she is using a new mask, which has made it harder for her to breathe. She also stated that she has Ataxia and cannot breathe well when she has a mask on. She denied her shortness of breath is caused by getting her vaccination. Client denied any issues with her first dose of Moderna.  Co-lead RN educated client via interpreter to seek immediate medical emergency care if she is experiencing any adverse reactions after she leaves vaccination site. EMT offered to take client out to the courtyard where she can wait without wearing a mask. She declined and insisted she was fine to go. She insisted her time was up and then left with her husband in a steady gait and in no distress at 2:20 pm.
A week after I received the first dose of the COVID Vaccine, I experienced an odd tingle/loss of feeling on my right side.  A few days later it became itchy and painful, then a bunch of painful sores appeared.  I went to the doctor and was diagnosed with shingles.  They prescribed me valacyclovir to ease the pain.
I started having a racing heart I can hear my heart beat in my ears, I was getting light heated.  I went to my Primary Care Doctor on April 23, 2021 for racing heart and every now and then I would feel light headed and he suggested that I see a cardiologist and I saw the cardiologist on April 29, 2021,  I had elevated blood pressure and heart palpations. Cardiologist ordered me and echocardiogram and I had to wear a Holter monitor they took blood work and did a cardiac check.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concomitant medication included sterile diluent. The patient's pertinent medical history, drug reactions and allergies were not reported. On 07-FEB-2019, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX lot # N025701, expiry date 16-DEC-2018 (strength, dose, route and site of administration were not provided) for prophylaxis. No adverse effects were reported.
This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were inadvertently vaccinated with improperly stored doses of PEDVAXHIB (lot #, expiry date, dose, strength, vaccination site, route unspecified). No adverse effect were reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of several reports received from the same reported. Additional information has been requested.
Arm soreness at injection site began a few hours after injection. About 18 hours after vaccine was given, experienced body aches, and tingling/numbness in arm that had injection and legs. Around this time also felt a little dizzy/light-headed.
Topical reaction red, raised area - looked by d. area, (after shots). It was diagnosed by dr. as Shingles after 2 weeks. (as per pt); and Pt is on antiviral.
This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 59-year-old female patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 17th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site induration. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the injection site swelling and injection site induration were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The caller was a nurse from healthcare professional office relaying information on behalf of provider. The caller relayed that the patient received SHINGRIX on left deltoid. The caller relayed that the patient complained of redness and hard swelling the size of baseball at the injection site. The caller relayed that the patient stated that the reaction started about a day after administration and had recovered. The caller relayed that the patient received 2nd dose of SHINGRIX (batch number TP5E5, expiry date 15th November 2020) on 17th July 2018 on right deltoid and till the date of reporting the patient had not informed her of any reactions with the 2nd dose of SHINGRIX. No further information provided. This is 1 of the 3 linked cases, reported by the same reporter.
Redness and swelling of (R) arm noticed the next day after the shot Seen office March 21, 2019 and March 23, 2019 Given Clavile 1 ty daily. Hot moist compress to area March 23, 2019, Swelling gone
pt recvd vax 15SEP95 small 2.5 cm abscess lt thigh @ immun site; mom denies elevated temp; mom noted purulent drainage from site p/applying warm soaks; rx Duricef/warm soaks;
Pt exp itching on legs 4 hrs p/recvd 1 dose of Engerix-B; did not have rash; itching is subsiding;
TEMP EXCURSION- VACCINE AT ROOM TEMP (68*) FOR >12 HOURS. PT HAD NO SIDE EFFECTS TO REPORT
This spontaneous report was received from a healthcare worker (medical assistant) and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 14-JAN-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K005402, expiration date 07-NOV-2015, exact dose and route of administration were not reported). It was reported that the patient was not exhibiting any adverse effects. No PQC (product quality complaint) was involved. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm and accidental underdose. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the accidental underdose was unknown. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient got the 1st dose of SHINGRIX about 4 months ago from the date of reporting. Afterwards his arm was sore for 2 to 3 days. About 1 week ago from the date of reporting he got the 2nd dose of SHINGRIX and after the injection a lot of fluid leaked out of the injection site. The patient thought he did not receive much, if any, of the dose, which led to accidental underdose. The patient arm had not hurt at all after the 2nd dose and he could not tell that he received anything at all. There was no consent to follow up.
I got the Pfizer COVID19 vaccine at a drive through site on 12/21/20 through Department of Health Services.  This morning I woke up in the middle of the night with lower spinal discomfort which has increased as the day has continued.  There is nothing visible on my spine externally that I noticed except a very faint pink line.
patient reports difficulty catching his breath beginning 5 to 6 hours after injection and lasting 3 to 4 hours.  breathing was helped by using albuterol (inhaler did not belong to him) and he reports that the next day he felt fine.
Patient experienced what he described as shooting pains throughout his body, namely his joints and in his abdomen one month after getting the Shingrix vaccine. The pain is intermittent but has been going on for days now. He reports no other symptoms. He has not seen a physician about this problem yet.
Patienty complained of symptoms of nausea, trouble breathing, tightness in chest,  feeling of syncope, itching,  tingling of tongue and lips, possible swelling of tongue.  ambulance was called and patient went to hospital.
Patient arrived for 2nd dose of COVID-19 vaccine. She was given Pfizer but was supposed to receive Moderna for her 2nd dose.
Hives and rashes developed on thighs, stomach and legs; Hives and rashes developed; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the  right arm on 11Jun2021 at 11:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to food, medications or other products. 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 medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jun2021 at 08:00, the patient experienced hives and rashes developed on thighs, stomach and legs. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event hives and rashes developed on thighs, stomach and legs was recovering at the time of this report.  The batch/lot numbers for BNT162b2, were not provided and will be requested during follow up.
Admitted with generalized weakness, lighteadedness and fevers, found to have covid-19 virus infection.   She was started on remdesivir to prevent any worsening.  Of note, patient was requiring 2L of nasal cannula to maintain her oxygen levels.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Mar2023 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Apr2023, outcome "recovered with sequelae" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Apr2023) Tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175732 same reporter/patient, different drug/event;
Patient came into office at health clinic on 06/21 with complaints of left sided facial paralysis that started 48 hours prior (06/19).  Confirmed diagnosis of Bell's palsy.  Started on Prednisone.  Only significant history was COVID-19 vaccination a few weeks prior (06/04).  He had some malaise and low grade fevers for several days after vaccination but then felt fine leading up to 06/19.  Unclear if any correlation but felt should be reported given there were cases of Bell's palsy in the clinical trials for mRNA vaccines.  Currently given Prednisone dosing for 7 days delaying 2nd vaccine.  Rescheduled from this Saturday to 3 weeks later.
administered an expired Boostrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 43-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number TG597, expiry date 9th March 2021) for prophylaxis.   On 5th July 2021, the patient received Boostrix. On 5th July 2021, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional information was provided as follows: On 5th July 2021, the patient was been inadvertently administered by expired dose of Boostrix which was expired on 9th March 2021. The reporter did not consent to follow up.
Around 2 weeks after the 2nd dose vaccine, I had severe sharp abdominal pain following by vomiting. I consulted with the doctor the following morning. I had to get blood work and the blood work showed elevated lipase levels, which can be indicative of pancreatitis. I went in for an ultrasound which showed a cyst on my pancreas. I also did an MRI which showed a cyst/lesion on my liver. The acute pain did resolve within 24 hours and I had residual cramping which resolved in a day or 2.
Low blood pressure, upset stomach, hot and cold chills, headache, lack of energy, And sore body.
Pt reported within hours of vaccination onset of severe shaking, weakness and "unable to walk", and "gray vision", "looked into the mirror and could not see anything at all". Day 2 symptoms did improve, however she reported feeling very weak.  On Day 3 symptoms improved.  Day 5 feels much better.  This patient has contacted office requesting that her symptoms be reported to the government.  States she has never had any issue with past vaccines.
Body aches Muscles and joint pain all over Headache Fever over 100 for over 24 hrs
Dizziness; Headache; Weakness; Nausea; Exhaustion; Pain and difficulty raising injection site arm; Pain and difficulty raising injection site arm; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 24Apr2021 at 10:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergies, hemiplegic migraines, penicillin allergy and allergy to certain opioids. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included salbutamol (ALBUTEROL) and acetylsalicylic acid/caffeine/paracetamol (EXCEDRIN), eye drops (unspecified) and birth control pill (unspecified); all for an unknown indication from an unknown date and unknown if ongoing. On 24Apr2021 at 10:30, the patient experienced dizziness, headache, weakness, nausea, exhaustion, and pain and difficulty raising injection site arm. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events dizziness, headache, weakness, nausea, exhaustion, and pain and difficulty raising injection site arm were not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
right arm developed hard lump at injection site 5 days after vaccine .  I lightly massaged it until lump got softer. Several hours later it had a deep purple bruise 1x1 nch. it was warm to touch. I went to ER and they said it was a reaction to the vaccine. . Did no tests. Barely looked at it.  Said  it was a hematoma. I asked why it took 5 days to develop and they said that it has happened to others. I have a hx of carotid artery blockage and blood clots and cardiovascular disease . They said it had nothing to do with that at all. I was quckly released and told I would be fine and it was nothing to worry about. Today, which is a day later..I have a significant headache. The  bruise is now 2x2 inches.
Breakthrough case admission after four vaccines  Moderna 3/12/21 Lot# 010A21A;  Moderna 4/9/21 Lot# 025B21A;  Moderna 12/2/21 Lot# 027H21B;  Moderna 5/13/22 Lot# 059M21A
Information has been received from a physician concerning a 12 year old male patient who on 23-AUG-1997 was vaccinated with the first dose of VARIVAX (Merck) (Lot not reported). On 03-MAY-2009 the patient developed a pustule vesicles and the physician diagnosed it as chicken pox. At the time of reporting on 01-MAY-2009, the patient's chicken pox persisted. Additional information has been requested.
Patient came in for routine health check and immunization.  Initially questioned mother about child being sick.  (Mother checked yes on questionnaire).  Mother stated child had a cold and was "hoarse", but had no fever.  Shots given about 30 minutes later child started to get warm and began wheezing.  EMS called.  Mother refused transport, but did state she would take child to ER.  Child did calm down and sounded better before she left facility.
In morning: temp - 101.3, injection site pain, redness, swelling, extreme pain at site. By evening: temp 103, general achiness, headache, dry cough. 05/06/2011 at 3:00 AM: Temp 105, severe headache, productive cough. Symptoms continued for 4 days. Residual local reaction at injection site continues with severe pain, swelling, redness, warmth causing limited range of motion left arm.
severe dizziness, elevated BP (210/110), no headache, no nausea or vomiting persistent symptoms with elevated BP--911 called
Developed itchy hives rash, inflamation, hot and hard at site of my first Moderna Covid vaccine (Jan 20, 2020); Moderna site was three inches below the flu injection site.   No redness at site of flu shot.  The "Covid" rash in January was memorable and lasted about 10 days.  The flu vaccine induced rash is diminished at 24 hours with treatment with benedryl and not as severe as the Moderna Covid rash.  I have never had any similar reaction to flu vaccinations received annually for the past 20 years, so I am reporting this event because it is new to me and because of its similarity, but not intensity, compared to the Moderna vaccination reaction.   I have not been diagnosed with Covid or knowingly been in contact with any Covid + individuals.