chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was retrieved on 18-Oct-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1713969-1), reported by other healthcare professional and concerned a 77-year-old, female patient. The patient's concurrent conditions included lung disease and doxycycline allergy. The patient's concomitant medication included clopidogrel and unspecified vitamin D, both used for unreported indications. On 19-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose reported as one, route of administration: intramuscular (IM), anatomical location: left arm (LA) and indication: not reported). The batch number reported was 312842. On the same day, after receiving Fluad Quadrivalent, the patient did not feel well during paying for her groceries in the store. The store employees assessed her with sitting on the bench and gave her some water. The pharmacist came to assist and checked her blood pressure which was at 170/88. The patient stated that she ate her breakfast, but they gave her sip of orange juice with a straw. The patient's face had a light sweat and she was extremely drowsy and in and out of coherence. As reported, the patient could state her name and asked the employees to call her boyfriend. Also, 911 was called even the patient did not want to call 911. The first responders checked her blood sugar and it was 120 (unit and reference range were not reported). They analysed her heart with an automated external defibrillator (AED), and no shock was advised. The patient was then transported to the local hospital by the emergency medical services (EMS). The outcome of the events was unknown. The reporter did not provide a causality assessment. This case is assessed as non-serious. Company comment: A 77-year-old patient experienced somnolence, incoherence, increased blood pressure, facial swelling, and malaise on the same day, after receiving after receiving the suspect product Fluad Quadrivalent. Although clopidogrel confounds causality, it is assessed as possible, due to plausible chronology.; Sender's Comments: A 77-year-old patient experienced somnolence, incoherence, increased blood pressure, facial swelling, and malaise on the same day, after receiving after receiving the suspect product Fluad Quadrivalent. Although clopidogrel confounds causality, it is assessed as possible, due to plausible chronology.
Patient received 3 boostrix vaccines within the past 6 months. One of 5/20/22, 9/22/2022, 10/9/2022. It was missed when doing a review of patients clinical history at the pharmacy. She has reported no adverse events at this time but would like to report   Patient also received 3 doses of shingrix. One on 11/22/19 , 3/6/2020, 10/9/2022. These were also missed in review of patients record since patient said she had not yet received her second dose. No adverse events have been reported at this time but would like to report
The patient is a 46 yo female professional emergency room registered nurse with a history of hypothyroidism and cosmetic breast implants in 1998 with revision in 2012, who required drainage of a seroma and removal of a left breast implant with symptoms onset temporarily associated with receipt of employer mandated IIV FLUARIX (lot # 7AJ5J) to her left deltoid. She states the vaccine was given at approximately 10 om on 23 Sept 2015. She states she experienced immediate pain during injection and felt that it was incorrect technique (needle placed against skin then pushed in rather than smooth motion) but appropriate placement in her deltoid. She states the pain is localized to the upper arm, sensitive to pressure and had a continuous ache of sufficient intensity to wake her from sleep. She states the shoulder was not affected and had normal range of motion. She states several days later she noted mild edema to her axilla and her left breast experienced intermittent sharp pains, but denies lymphadenopathy. On October 3 she noted a continuous ache on her left breast and it was slightly hard and erythematous. Within 12 hours she had severe pain and was seen in the emergency room at hospital. Ultrasound was normal and she was treated with KEFLEX and released. She had no fever chills malaise arthralgias or myalgias. She states she had no fever on arrival to ER, but self checked because she felt hot while she was there and registered a temperature of 101.7. In 24 hours she developed erythema on the outer aspect of her left breast and was again seen by her surgeon and received IM ROCEPHIN and prescription for SEPTRA and AUGMENTIN. She was scheduled for surgical exploration and possible I and D on Thursday, October 8. On Tuesday, October 6 she woke with 'angioedema' described as edema to her upper lip and puffiness to her chin and mild pruritus to her lower extremities. She denies urticarial lesions, oral lesions, throat edema, conjunctivitis, rhinorrhea, dyspnea. Wheezing, chest pain cough, nausea, or emesis. She stated had mild anxiety but attributes to concerns for her health. She felt generalized malaise. She was seen in ER and again ultrasound did not demonstrate abnormalities. On Wednesday, October 7 the surgery center performed I and D and reported she had a sterile seroma. The culture was negative,  and the implant was intact but they remove the implant anyway. She reports the surgeon stated he has seen seromas secondary to vaccine receipt.
Breakthrough case admission after 2 vaccines ; Moderna 1/29/21 lot# 010M20A; Moderna 2/25/21 lot# 011A21A
I am an RN in a pediatric practice and take the Influenza Vaccine yearly.  Approximately 32 hours after receiving the Influenza Vaccine, I had severe vomiting and fever of 102 degrees.  I used Phenergan and Tylenol for symptoms.  These same adverse symptoms have been reported verbally to me by several other people in the community after they had received the Influenza vaccine in less than a 48 hour period.
POSITIVE COVID TEST 9/6/21. COUGH AND SINUS CONGESTION. LOSS OF TASTE AND SMELL. RACING HEARTBEAT AND SHORTNESS OF BREATH.
Information has been received from a male consumer of unknown age via Pfizer referring to himself. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown)(reported as "PPSV23 Pneumonia shot"). (lot#, dose, and route not reported). On an unknown date the patient experienced side effects (unspecified). The outcome of the side effects was unknown. The causality was not provided by reporter. Additional information has been requested.
SOME SWELLING IN RIGHT HAND. PAIN AND BURNING SESSATION IN INJECTION SITE. RIGHT FOOT SWOLLEN SOME. MINOR HEADACHE. VERY FATIGUED.
received  2nd shot at 1:oo in the afternoon , at approximately 230 am , i awoke to severe  back ad hip pain, along with nausea and violent dry heaves for 3 hrs.    First 24 hours  after that  i felt extreme pain still, involving all my joints, still nausea but no longer dry heaves.  Extreme weakness, headaches, fatigue, and pain.  .  Friday, May 28th , still feeling poorly with pain, fatigue, weakness but as daytime turned into early evening time, im finally slightly feeling better.  i was sooo sick 48 hrs ago.
pt recvd vax & exp thirty to forty lesions; reporter felt that lesions were related to vax;No further details were provided;
This spontaneous report as received from a nurse via company representatives refers to a 15 year old male patient. None of pertinent medical history, drug reactions or allergies were reported. On 19-FEB-2013 the patient was vaccinated with a first dose of GARDASIL (lot#, strength and route were not reported). Then, the patient's received his GARDASIL shots outside of the recommended time intervals: the second dose on 11-JUL-2013 and third dose on 16-SEP-2013. The patient did not seek medical attention. None of lab diagnostics studies were performed. No adverse symptoms were reported. No treatment was given for the patient. The outcome of patient's events was not reported. Additional information has been requested.
Pt received the intraderma flu vaccine on 11/8/13.  She started experiencing watery itchy eyes, nasal drainage, extreme sore throat, diarrhea, generalized body aches, and swelling with induration about the size of 4 inches in diameter.  Upon examining associate's arm, redness and warmth was noted to be approx. 4 inches in diameter with sensitivity to touch.  She still reports aching, itchy, watery eyes, sore throat, nasal drainage, and diarrhea.  I provided education of an adverse reaction versus an allergic reaction and encouraged her to meet with her physician with this concern in anticipation for next year's flu season.
This case was considered medically important for the event of child maltreatment syndrome. Information regarding Prevnar was received from a consumer regarding a patient who received a dose of expired Prevnar on 25-Sep-2007 and experienced "shaking baby." On 25-Sep-2007, the patient received a dose of expired Prevnar. On 27-Sep-2007, the child experienced "shaking baby". As of 11-Oct-2007, the patient was still alive, but will "probably not make it." It was unknown if the patient recovered from the event. No additional information was available at the time of this report.
Patient was given the regular Pfizer 12+ vaccine  instead of the Bivalent Pfizer 12+ booster dose
Amenorrhea, Delayed menstruation by 14 days. I have a normal & very regular menstruation cycle of 25 days. My last menstruation before booster shot was Nov 26th, 2021. I got the Booster on Dec 10, 2021.  I got my period on Jan 4, 2022 - 39 days in this cycle, with delay by 14 days. I have never had a delayed period ever before.   On Item 20 below - I have said "Unknown" for has patient recovered because while I my period has started, I have no idea what effect or impact this delay has had on my ovaries.
Shortly after vaccination, patient passed out while sitting, he fell out of the chair, hit his head on the floor, regained consciousness within 10-15 seconds, patient stayed laying down with legs elevated, patient vitals taken (pulse rate 60 blood pressure 120/70 respirations were 18) patient given juice and granola bar, monitored for about 40 minutes at which time he reported his symptoms had greatly improved, he was also offered transport with EMS but patient declined, patient has someone to transport him home, he was advised to follow up with his doctor as soon as possible or to go to the ER if he were to develop any symptoms.
patient had nausea, headache, hot and itchy eyes and ears. Patient was given 25mg Benadryl and 4mg zofran
Profuse sweating but felt ice cold.  Felt weak, nauseated, couldn't get out of bed.  Flu-like symptoms.  Today she is feeling so-so, nauseated, not cold.
Unlike any of three previous vaccinations, I experienced 2 hours of severe rigors with intense muscle contractions, enough to result in pulled groin muscle, and with hyperventilation.  40 hours post injection I am about 80% recovered, but still feeling malaise and muscle pain (secondary to rigors?).  This was all severe enough to be disturbing, quite different from the normal reactions I had to earlier shots in the series. Not life threatening but bad enough that I wanted CDC to be aware
Information has been received from a registered nurse concerning an 8 year old female who on an unspecified date was vaccinated with a second of VARIVAX (Oka/Merck) (lot# 66164/0974X). Concomitant therapy included a dose of influenza virus vaccine (unspecified). Twelve days after the vaccination the patient developed a varicella reaction at the injection site. The varicella reaction was described as localized at the injection site, painful and pox like. Subsequently, the patient recovered from the varicella reaction. This is one of several reports from the same source. Additional information has been requested.
Pt presents to the clinic today with her mother for an ER follow up for a reaction to immunizations. Requesting referral to allergist. She is currently taking an oral antibiotic (SEPTRA and Antibiotic Cream (BACTROBAN). Received immunizations: KINRIX left thigh and Hep B right thigh on 4/14/16. Seen in ER 4 days ago (4/15/16) with local redness and swelling left thigh, painful and itchy. Diagnosis: cellulitis. (Small red spot rt thigh without spreading).The patient was seen again in the ER 2 days ago (4/17/16) for spreading redness in the left thigh. Thigh U/S no abscess. Diagnosis: reaction to KINRIX. Similar incident involving both thighs 2 yrs ago after Hib, IPV, Hep(B), PCV immunizations. No hives or breathing problems. Patient is well today (4/19/16) except for a lump in both thighs.
This spontaneous case reported by a pharmacist, describes the occurrence of accidental underdose (received a booster instead of a third dose/immunocompromised patient given 0.25mL dose for the third dose, instead of a full dose of 0.5mL) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 017F21A) for COVID-19 immunization. Concurrent medical conditions included immunocompromised. On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 0.25 milliliter. On Nov 10, 2021, patient experienced accidental underdose (received a booster instead of a third dose/immunocompromised patient given 0.25mL dose for the third dose, instead of a full dose of 0.5mL). On Nov 10, 2021, accidental underdose (received a booster instead of a third dose/immunocompromised patient given 0.25mL dose for the third dose, instead of a full dose of 0.5mL) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Most recent follow-up information incorporated: On Nov 12, 2021: significant follow-up appended, reporter details, patient demographics and patient's current condition updated.
About 5-10 min after vaccination given, the patient had a blank stare, turned gray, rapid breathing, got stiff eyes, eyes rolled back, arm and legs stiff and shook some, + urinary incontinence. No h/o seizures in the past.
12-10-18 at 9:39 AM Patient called complaining of increased redness, swelling and warmth over right arm from injection site wrapping around arm and almost reaching elbow, with limited ROM in right arm per patient, patient states she received pneumonia and flu vaccine on 12-7-18. Recommended patient come in to walk-in this AM for evaluation, patient voiced understanding and agrees with plan of care. 12-14-18 at 3:51 PM Pt called and said had gone to the ER, they suspected cellulitis and was put on KEFLEX. Wasn't able to start ABx till Tue (11th) because of allergies and what the original Rx was. She said the swelling, redness and hardness has gone but still has pain on the backside of the arm from the elbow up to shoulder. She said it was a very painful experience and never had a reaction like that. She says if the pain persists, will come in on Monday. I told her I was going to fill out a report about this. Emergency Department (ED) 12-10-18 at 11:35 AM: HPI: Female who presents with report of redness, swelling, tenderness in the right deltoid region. She tells me that she received a flu shot and PNEUMOVAX shot the day before yesterday. They were both in the right deltoid region. She told me that the flu shot went "just fine", but the PNEUMOVAX she "really felt it when it went in". The next day, she developed redness, swelling, erythema in the injection area which she feels as though is getting worse despite TYLENOL and ibuprofen. No other frank signs or symptoms associated with this such as fever, chills, numbness, tingling and neurovascular dysfunction. ED Course: The redness, swelling, tenderness seems to be more of a local reaction to the vaccines as opposed to an infection. In discussion with the patient though, I am not opposed to prescribing a short course of KEFLEX with primary care follow-up. The patient is very much in agreement with this plan. This does not appear to be an allergic reaction. No pruritus, no systemic signs or symptoms. Recommend continuing TYLENOL/ibuprofen and adding a warm compress as well. She verbalizes an agreement and understanding. Follow-up with primary care, otherwise return to the ED for any emergency problems or concerns.
sore & swollen lt arm, lt axillary 3x4 cm adenopathy, n/v, chills, fever 101.8, weakness, dizziness x 2 days; rx w/Duricef x 6 days
SHORTNESS OF BREATH; MALAISE; FEVER; This spontaneous report was received from a 75-year-old female patient via a physician. The patient's height, and weight were not reported. The patient's concurrent conditions included pulmonary arterial hypertension and sinus infection due to seasonal allergies. The patient received macitentan (OPSUMIT) (tablet, form of administration:10 mg, oral, batch number was not reported) 10 mg, daily, from 23-JAN-2020, frequency was not reported for pulmonary arterial hypertension.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number were not reported) dose was not reported, 1 total, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the patient experienced fever which was treated with Tylenol (paracetamol). On 12-APR-2021, her fever returned and was accompanied by shortness of breath and malaise, following which she was hospitalized in the afternoon. It was reported that the patient had a possible reaction to the vaccine. At the time of report, the hospitalization status was provided as 'current'/'not resolved'. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of macitentan was not changed. The outcome of the malaise, shortness of breath and fever was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 : 20210440876-covid-19 vaccine ad26.cov2.s -SHORTNESS OF BREATH. This event is considered not related. The event 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 than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE 20210440876-covid-19 vaccine ad26.cov2.s -MALAISE, FEVER. This event(s) are labeled per RSI and is therefore considered potentially related. 20210440876-OPSUMIT-SHORTNESS OF BREATH,MALAISE,FEVER. This event(s) are 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: CONMEDS-OTHER SUSPECT DRUGS
Raised heartrate / 77-80 beats per minute; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Raised heartrate / 77-80 beats per minute) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced HEART RATE INCREASED (Raised heartrate / 77-80 beats per minute). At the time of the report, HEART RATE INCREASED (Raised heartrate / 77-80 beats per minute) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Fever for 48 hours. Severe body aches, headache, chills and nausea, followed by a 8 day constant  headache.  Resulted in a visit to urgent care and a CT scan. At urgent care, blood pressure was a constant 166 or higher.
Information has been received from a pharmacist referring to a patient of unknown age and gender. On 29-FEB-2016 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose unknown, strength: 25 (unit unknown), lot # K010523, expiry date: 25-FEB-2016, intramuscular). No known adverse effects were reported. Additional information has been requested.
extreme feeling of anxiety and need to leave a room full of people. Hands went numb, legs were shaky and broke out in cold sweat.
Red rash; diffused rash; Chest pain; Shortness of breath; This case was reported by a physician via call center representative and described the occurrence of chest pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chest pain, shortness of breath, red rash and widespread rash. On an unknown date, the outcome of the chest pain and shortness of breath were recovered/resolved and the outcome of the red rash and widespread rash were unknown.   It was unknown if the reporter considered the chest pain, shortness of breath, red rash and widespread rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed sudden onset of chest pain and shortness of breath and a couple days later she developed a rash. The physician stated the shortness of breath and chest pain completely resolved within 2 minutes because the patient used her inhaler. The physician described rash as red and diffuse.  The outcome for rash was not provided The reporter did not provide patients initials or date of birth, lot number, or expiration date. The reporter consent to follow up.
Information has been received from a physician concerning a 4 year old female patient who was vaccinated with RECOMBIVAX HB (total number of doses not reported).  Subsequently, the patient did not seroconvert after being administered the RECOMBIVAX HB vaccine.  Additional information has been requested.
Fever up to 102, on 6/13 and & 6/14 ; fever resolved and on 6/15 AM - chest pain and shortness of breath.   Went to ED - EKG with ST elevation, Troponin > 3.  Transferred to hospital
8/10/17 5:00 pm Approximately 2 1/2 hours after injection, sudden onset of extreme pain-difficult to raise arm/shoulder. Took 1 ALEVE. Pain worsened to "10"-took 1 NORCO at 9 pm. Right arm was swollen, hard, and hot to touch-some itching feeling and redness around armpit/inner arm-used topical BENADRYL cream and iced. No fever. 8/11/17 Little or no sleep-pain continued-took 1/2 NORCO-2 am headache developed-took regular TYLENOL-9am called Dr.-appt at 10:30 w/Nurse Practitioner by mid morning-pain lessened, but arm (from shoulder to elbow) still swollen, hard, red, and hot. Instructed to start oral BENADRYL and keep icing sleeping rest of day.  8/12/17 Less pain-less swollen and hot to touch still itchy-Ice packs, 1 ADVIL, BENADRYL oral and topical used. 8/13/17 Felt weak but (R) arm swelling and hot feeling reduced. Headache (stopped oral BNEADRYL). 8/14/17-8/21/17 Tiredness continued with headaches for a week-a general "unwell" feeling. 8/22/17-Feel normal.
Miscarriage at approximately 11 weeks 2 days.  1st pregnancy.  Estimated due date Oct 7, 2021.
Fever 102, extreme dizziness, nausea, vomiting, horrible ringing in ears, site of injection very hot and very swollen.
I experiencing ongoing cold symptoms deep with in chest, lost of energy, foggy, achy joints in the hips, back, wrists, memory loss, and other symptoms after receiving the vaccine. I went to different Doctors:  (Neurologist). Dr.  felt that my symptoms are related to COVID and all the Doctors asked that I continue to come in so they can evaluate my condition. Dr.  correlated my post stroke to having COVID previously and I have not seen her since 04/14/2021. Blood work was taken and the results came back normal. I am still suffering from the symptoms because my body is not allowing me to recover to where my energy levels pick up.