chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an office manager concerning a 18 year old male patient with a history of birth twin who on 14-JUN-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (lot number unspecified). The office manager reported that after the three doses of RECOMBIVAX HB were given to the patient, all blood work (hepatitis B surface antibody) came back negative, not immune (lab was less than 5); requiring a fourth dose of the vaccine. The patient received lot # 603895/0748V but it was unknown which dose. At the time of the report, no follow up laboratories had been performed yet. The patient did not develop hepatitis B. No adverse experience was reported. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. The office wanted to know if lot# 603895/0748V was associated with failed immunity. Follow up information has been received from the office manager who reported that on 02-DEC-1992 (at the age of 7 months) the patient was vaccinated with a dose of RECOMBIVAX HB (lot number lot# 603895/0748V), (adult dose vaccine; actual dose unspecified), as an infant. The office manager could not confirm if the vaccine was stored correctly back in 1992. Follow up information has been received from the office manager via medical records concerning a currently 18 years old male patient who on 11-MAY-1992 the patient received his first dose (lot # unknown), 11-JUN-2002 he received his second dose (lot # 602638/0310V), and 02-DEC-1992 was vaccinated with the third dose of RECOMBIVAX HB (Lot # 603895/0748V) into the left leg. Concomitant vaccines given on 20-NOV-1992 included the third dose of Hib conj vaccine (unspecified carrier) and the third dose of DTaP. It was reported that on 25-JAN-2010, a hepatitis B surface antibody (quantitative) was performed and the results showed <5. The physician stated that the patient needed a booster in 1 month. On 14-JUN-2010, the patient received a fourth dose of RECOMBIVAX HB (lot # (manufacturer unknown; lot # AHBVB789AA). On 30-JUL-2010, a hepatitis B surface antibody (quantitative) revealed 20 mlU/mL; patient had immunity to hepatitis B virus. A lot check had been initiated. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of RECOMBIVAX HB. Additional information will be provided upon finalization of this manufacturing investigation. This is one of several reports received from the same source. No further information is available.
Swelling, Pain, Erythema to middle of L. arm at site of innoculation. Did not involve joints.
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 2/19/2009 with COPD exacerbation. Vaccination took place on 11/7/2007. According to the physician, the relationship is 'Unlikely'. We would be happy to forward the Study's SAE reporting form upon request.  4/23/09 Received SAE report of 2/19-2/23/2009. FINA DX: COPD exacerbation likely secondary to respiratory infection, continued cigarette use & under-utilization of COPD meds. Records reveal patient experienced worsening wheeze, increased productive cough of yellow sputum & SOB at rest beginning 2/15/09.  Had episode of unresponsiveness 2/18.  Tx w/IV antibiotics, steroids.  Transferred to nursing home.
Patient developed a fever to 103 and pleuritic positional chest pain the day after receiving dose #2. He presented to the ED 2 days later on May 21, 2021. An ECG showed acute pericarditis.  His TnI was mildly elevated. An echocardiogram showed mild LV dysfunction with LVEF 40-45%. He was diagnosed with myopericarditis.  Treatment included NSAIDS and colchicine and metoprolol.  He was not admitted to the hospital.
pt recvd vax & fainted;pt drowsy;pt appeared nervous & was quiet throughout the procedure;
24 hrs p/vax, pt c/o temp to 104, chills, abdo cramping, myalgias; also c/o red, sore area around inject site; sx lasted about 3 days;
Reports of having redness, swelling, tenderness from right shoulder half way to elbow. Seen in ER 7/21 - given pain med and advised to use ice packs. Report swelling x2 week. Last Td in ER in 2005.
6-8-17. On March 26th 2017-I got the pneumococcal vaccine at my drug store given by the pharmacist. I immediately became ill-by Wed-March 29th I was in hospital with pneumonia and have been in this hospital 3 more times. They can describe my illness and the time I spent there. I have always been healthy as right now at age 84. I am on a blood thinner.
Approximately 10 days after the vaccine, I had extreme joint inflammation from my shoulders down to my ankles.  It eventually passed after taking anti inflammatories for about 4 days.
I received the 2nd dose of the Pfizer vaccine on 1/11/21 around 9:30 am. Starting around 1 pm on 1/11/21, I started experiencing burning nerve pain in my left foot. This pain lasted about 5 weeks, fading in intensity over time. I have previously experienced this pain before (starting around 9/1/19 after spraining my ankle); however, this pain was resolved by the beginning of May 2020. So it felt like the 2nd dose of the vaccine had triggered this previous pain. I did not seek treatment for this issue. It resolved on its own.
expired vaccine used/ patients received Moderna vaccine between 4/8/2022 and 12/15/2022; no adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used/ patients received Moderna vaccine between 4/8/2022 and 12/15/2022) and NO ADVERSE EVENT (no adverse event) in a 45-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used/ patients received Moderna vaccine between 4/8/2022 and 12/15/2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used/ patients received Moderna vaccine between 4/8/2022 and 12/15/2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine used/ patients received Moderna vaccine between 4/8/2022 and 12/15/2022).    Patient age was reported as 45 Year 2 Month. No concomitant medication was reported. No treatment medication was reported.
My arm....became swollen & Stiff....as of today....day 3 I can't....even move....my arm up & down.... my left arm & hand....is in alot....of pain!!!!! I can barely type arm, shoulder, & hand is pain & I have a red blotch were shot was given!!!!!!!! I'm in alot... of pain....didn`t sleep....well!!!!!!!!!
This spontaneous report as receive from a physician via field representative refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 03-JUL-2015, the patient was vaccinated with the expired dose of M-M-R II (lot number J006954 and expiration date 07-JUN-2015) (dose, route of administration not reported). No adverse effect was reported. Additional information has been requested.
Very light headed . Faint like feeling .EXTREME  back pain. Fever, loss taste & smell. Very weak,   Naseau . chills  but received on wed afternoon & Friday morning I?m improved with light headed not as extreme , but still linger back pain just like the first vax . I took moderna  vax . Everything  has been an effort just getting out of bed but feeling somewhat human this Friday morning. I think it would help if people knew some have a reaction & take off work day after the vax if possible.  It?s worth it if it can prevent covid but I not antipate feeling this bad
chills, cough, shortness of breath and headaches  May continue to take over-the-counter medication for symptoms such as Tylenol/ibuprofen for fevers and body aches,
red marks on her upper chest and back spreading down her arm; spots looked like hives flat on the skin; Itching; 1st dose Aug 4th 2021 2nd dose Sep 13th 2021; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red marks on her upper chest and back spreading down her arm), URTICARIA (spots looked like hives flat on the skin), PRURITUS (Itching) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Aug 4th 2021 2nd dose Sep 13th 2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesteraemia. Concomitant products included ALIROCUMAB (PRALUENT) for Hypercholesteremia, METOPROLOL, ACETYLSALICYLIC ACID (BABY ASPIRIN), GABAPENTIN and CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) for an unknown indication.    On 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced RASH MACULAR (red marks on her upper chest and back spreading down her arm), URTICARIA (spots looked like hives flat on the skin), PRURITUS (Itching) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Aug 4th 2021 2nd dose Sep 13th 2021). At the time of the report, RASH MACULAR (red marks on her upper chest and back spreading down her arm), URTICARIA (spots looked like hives flat on the skin) and PRURITUS (Itching) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Aug 4th 2021 2nd dose Sep 13th 2021) had resolved.            No treatment drugs were reported   This case was linked to MOD-2021-325429 (Patient Link).
This case was reported by a physician and described the occurrence of crying in a 4 month old patient who received PEDIARIX. On an unspecified date in either August or September 2004, the patient recieved the second dose of PEDIARIX in the left leg. At an unknown time post -immunization, on an unspecified date in either August or September 2004, the patient experienced an "uncontrollable crying episode." The event resolved on an unspecified date.
For two+ days after Moderna booster (Pfizer 1 & 2 vaccine) I experienced moderate to severe side effects. They include: severe muscle pain throughout my body, high fever of 101.3+(my normal is 97.4), severe dehydration symptoms, extreme thirst, muscle cramps, pain in right lymph nodes under arm getting shot, severe chills, reduced taste and smell, sweating, no appetite, soreness at injection site. I got no relief from increasing fluids (water, coconut water, Gatorade, taking aspirin, taking NyQuil,and trying to rest. I almost went to the emergency room. I had very mild symptoms (sore arm, slight weakness) for less than 8 hours after Pfizer vaccine 1 & 2. I fully support COVID-19 vaccinations as I have pre-existing conditions but did not expect this. I was going to get a Pfizer booster but was given an earlier opportunity for Moderna which I accepted. I was a bit run down before getting the booster due to my pre-existing conditions. I'm not sure of a solution but feel the FDA should know. Perhaps mixing Pfizer and Moderna is not a good idea. I regret it.
Patient developed fluid filled vesicles on the lips around 12 hours after receiving both a flu and COVID vaccine. At the time the vaccine were administered there was a red inflamed lip due to acne where the vesicles appeared that appeared likely to be due an bacterial infection. The patient went to urgent care the day the vesicles on the lips appeared and was prescribed a 24-hour course of Valtrex and 7-day course of antibiotics. Despite treatment the patient went to the ER and was admitted to the hospital three days after the vaccines were administered with Herpes Zoster spreading from the lip up to the edge of the eye on the same side of the face. The patient was in the hospital for three days and was switched from oral Valtrex to to IV Valtrex to stop the spread the Herpes Zoster from spreading. Oral Valtrex did little to slow the progression of HZV. Patient was discharged from the hospital with shingles rash drying and some some limited inflammation in the cornea that managed successfully with steroid eye drops.
Pt recv vax & exp fever,flu-like sx & itchy rash. 18Mar98 pt to ER for itchy rash & fever.
He tested positive for Covid-19; This is a spontaneous report from a Pfizer sponsored program . This consumer reported for a male patient (husband). A male patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on 10Mar2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. patient received his first dose on 10Mar2021, and then he tested positive for Covid-19 on 15Mar2021. tested positive for covid for like a week and a half now. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 15Mar2021.The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
She received the Moderna COVID-19 vaccine and was seen in our office on 3/1/2021. It was administered in her right arm. She said later that day she had itching on her arm, tachycardia, short of breath with wheezing, felt like she could pass out, muscles felt like jelly. She had to use her husband's supplemental oxygen. Later that night she felt pressure behind her left eye as if it was ready to explode. She felt dizzy When she would try to walk, she would feel so weak that she felt like she could pass out. She then developed a feeling of pressure like an elephant sitting on her neck and her chest. It was hard for her to take a deep breath. Her pulse would sometimes go up to 114. She had headaches. She has felt like she cannot focus or concentrate. She has been using Benadryl 25mg every 4-6 hours since the reaction started. When she goes about 12 hours without the Benadryl she starts to feel short of breath and the chest heaviness again. She was given Depo-Medrol 80mg injection in the office that day. She will continue taking the Benadryl until she is no longer having a reaction.
Fever 102, severe weakness in wrists and hands primarily. For about 8 hours. This started at 7pm. Could not hold a cup or cell phone to text family. I have no prexisting issues with the arms hand or wrists and never experienced. 10pm fever spiked again with very loud ring in ears. On a scale of 1-10 if was an 8. Almost passed out twice earlier on 04/23around 10am. Extreme fatigue like more than I ever experienced before. Could not stay awake for conversations. I did have the usual arm and neck pain and body aches but I kind of expected those. I still have a low grade fever at 1154am on 04/24 while I'm typing this so my wrists are back to normal.
Symptoms started today (Day 7 after vaccine)- swollen, redness, warmth, itchiness at site of injection with swollen painful lymph node in the left axilla which started on day 6 accompanied by some mild chills and body aches... started today and hasn?t changed with taking loratadine and Advil
12/28/20  Patient received Moderna COVID19 vaccine for first injection of 2 shot series.  Patient developed right arm sorness later that day.  No other symptoms and sorness left within two days.  Patient presents today with reddness to right deltoid approx 4-5 cm reddness around where injection was placed.  Site is noted to be warmer than surounding tissues.  Patient also notes throbing dull ache to site and down arm.  Rates pain at 2 -3.  Also notes more slower responsiveness of this muscle group when preforming power cleans and working out.  No fever noted.
Extra dose of Pfizer covid vaccine was given too early. Pt came to vaccine clinic on a walk-in basis requesting 2nd Pfizer vaccine dose. He presented a vaccine card with 1st Pfizer dose as being given on 10/1/2021. Therefore another Pfizer dose was given. Upon documenting the visit, it was discovered that pt actually received the 1st Pfizer covid vaccine on 11/1/2021. 2nd dose was given 11 days after 1st dose.
He comes to the hospital today after sustaining a fall. Information from the ER physician is that the patient states he was getting out of bed, slipped onto his left hip and was unable to stand up again secondary to the pain and was on the floor for a prolonged amount of time.  Eventually EMS was called and brought the patient to the emergency department.  He is a very poor historian when I evaluated him in the emergency department.  In fact he was fairly somnolent, he did have some morphine earlier.  He would open his eyes but just mumbled answers to my questions.  He was able to tell me who he was, where he was, and what year it was, and that he hurt his left hip but other than that he was really not able to give any other information with regards to his HPI.  I told him that he was positive for Covid, asked him if he had any respiratory symptoms and he denied.  I asked him if he knew how he contracted it and he shook his head no.
She slept 35 hours after the shot. Said she thought she was having a reaction. She died of presume heart complications of an aortic dissection or stroke
Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. On 12-JAN-2016 the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L038018/L027733, expiration date 13-SEP-2017 (dose, dose #, route and application site were not reported). The reporter was not aware of any adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Raised, red, warm, swollen area approximately 2 inches in diameter and 2 inches down the arm from the injection site.
1st shot: low grade fever, diarrhea, fatigue, flu-like symptoms for 2 days. 2nd shot: tremors in (L) hand w/in 45 min. Followed by sharp pains in both ears (inner) w/diminished hearing, followed by a fitful night of rest a/c sharp pains in legs, arms, shoulders, neck affecting my sinuses and head congestion. Woke w/ 99.8 degree temp. and had a terrible time walking w/o help...spent next 2 days in bed. This was accompanied by reduced cognitive abilities...serious brain fog and a series of inflammatory bouts in extreme-tics along w/IBS. I lost 6 lbs w/this bout (reaction) and still have problems w/fatigue 14 days after 2nd dose of herpes zoster vaccination. Today as I write, I am experiencing swelling and pain in my right hand. Some nights I still experience pain in my right arm and pain in my right hip that travels down my thigh. Throughout this time following my 2 shots of this herpes zoster vaccination I have experienced an accelerated heart rate on and off...it seems to happen at night more often. When this occurs during the daytime I occasionally feel a little dizzy and weak. When I experienced the most problems, after the 2nd shot, I called the office to report these things but got the message of too many calls were coming in and no available operator. Note: I broke out w/shingles on my left back behind my ribs maybe 2-3 wks after my 1st shot. I told the nurse who gave my 2nd shot and she looked and confirmed that it was still there. Note II: 7/10/18: still experiencing muscle, tendon and ligament pain intermittently throughout my body. 2nd dose on 6/22/18.
swelling; skin around the chin became hard and hyperemic; skin around the chin became hard and hyperemic; Swelling began to spread to lower lip; Bruising; This is a spontaneous report from a contactable healthcare professional. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Apr2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation; hyaluronic acid (RESTYLANE injection), via an unspecified route of administration from 06May2021 (Batch/Lot number was not reported), at 0.5cc to the lips for an unspecified indication; and botulinum toxin type a haemagglutinin complex (DYSPORT injection), via an unspecified route of administration from 06May2021 (Batch/Lot number was not reported), at 180U to the glabellar, forehead, crows feet and platysmal band for an unspecified indication. The patient was also injected with 1cc restylane defyne (lot 18567) and Restylane Lyft to the cheeks, via unspecified route of administration from 06May2021 for unspecified indications. Medical history included osteoporosis, thyroid condition, and hypertension. The patient's concomitant medications were not reported. The patient previously took thyroxin, vitamin d [colecalciferol], biphosphonate, lisinopril sertraline, and vitamin B7. The patient previously received bnt162b2 for covid-19 immunisation in Mar2021. On an unspecified date, the patient had significant swelling within 5 minutes of the restylane defyne and swelling increased quite a bit, skin around the chin became hard and hyperemic, it really looked bad. Swelling began to spread to lower lip during the appointment. After about 12 minutes, the reporter stated that she injected the chin with 3cc of hylenex and noticed it softened after about 5 minutes, but still swollen; used nitropaste, warm compress and gave prescription for 40 mg prednisone which she reported patient took at 17:00 and the event was resolved by 20:00. The reporter stated that the patient had only had some bruising left from the hylenex. It was also reported that patient has had all the products mentioned before on 19Dec2020 without use. The patient has not had any other vaccine in the last 6-12 months, no illness reported in the last month and no dental procedures in the 6-12 months. The action taken in response to the events for hyaluronic acid and botulinum toxin type a haemagglutinin complex was unknown. Outcome of events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the reported events with BNT162b2 can not be completely 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.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The medical assistant reported that the unspecified patient received the first and second dose of GARDASIL inj (doses, lot numbers and routes not provided) on unspecified dates in 2011, and was in the office on 25-AUG-2014, to receive the third dose of GARDASIL. No adverse effects reported. Additional information has been requested.