chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a 79 year old male patient via other company (Mfr. control # 2016USA032459) and refers to himself. The patient's concurrent conditions included prostate cancer. No information on the patient's concurrent conditions and medical history was reported. On 03-AUG-2016 (also reported as 04-AUG-2016), the patient started the therapy with XTANDI 40 mg capsule, orally, 160 mg once daily, for prostate cancer. On 18-AUG-2016, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), (dose, route of administration, lot number and expiration date were not reported). Concomitant therapies included gabapentin, levothyroxine sodium (manufacturer unknown), lisinopril (manufacturer unknown), LYRICA, magnesium oxide, oxybutynin and simvastatin (manufacturer unknown). On 18-AUG-2016, the patient's arm, from elbow to shoulder became red, sore and swollen. On an unknown date in August 2016 (reported as "a few days ago"), the patient had a pneumonia shot (unspecified) and his arm broke out. No lab test information was provided. The therapy with XTANDI continued. The outcome of elbow to shoulder swollen, red and sore was reported as not recovered/not resolved. The outcome of arm broke out was reported as recovered/resolved on an unknown date in August 2016. The relatedness between the events and the suspected therapies was not reported. Additional information has been requested.
slightly elevated temp (99 deg), chills, body aches, headache over 18 hrs period
Pt. was hospitalized with acute hypoxic respiratory failure due to severe COVID-19 complicated by acute kidney injury and exacerbation of heart failure on 2/8/2021.
Vaccines given 8/28/08 at 14:00 pm. Mom notice a couple flat red dots (not raised) on his back last evening. Had slight fever, gave Tylenol. Today when getting him dressed, noticed same rash, but more on back and inner thigh. When getting on bus, noticed on neck too. He complained of itching all night. No fever this morning. She is going to call physician to see if they want to evaluate him in the office or use other than counter medications.
This was after receiving the Moderna Booster:   Chest pain (feeling of constant tightness, lasted approx 24 hours), increased heart rate (between 89 - 125), shortness of breath, reduced oxygen level (between 88-93), extensive joint pain where it hurt to walk, muscles aches, headache, tiredness, severe chills and could not get warm (house was 75/76 degrees and I had on full pj's, furry robe and blanket and couldn't get warm)
Fever, chills, shortness of breath,headache, chest pain, lower abdomen,/side pain, fever,  asthma flare up
4inch circle raised, hot, red area in lower part of upper arm near elbow and a large bruise on back side of arm (middle) and pain in whole left arm where shot was given; lasted 4-5 days.  Pt took ibuprofen.
The next day after receiving my second dose of the Moderna vaccine, I began having severe pain in my left shoulder where I had a rotator cup surgery done back in 2009, and in  the arm and fingers of my left hand where I had carpel tunnel surgery done back in 1998.  It has been 15 days since the 2nd shot and the pain is still with me, along with some swelling in  my left shoulder.
Cellulitis, upper arm (acute). LUE pain/swelling/redness - blistering. Abx AUGMENTIN 500/125 BID x 10 days. Naproxen 500 BID PRN. SILVADENE BID topical/NEOSPORIN topical BID.
Patient was given the diluent only in error. No adverse signs or symptoms. Patient will need additional immunization.
Presented to the ED with deltoid/tricep area tender, swollen, erythema, increased warmth. Discharged to home, diagnosis cellulitis right upper arm. Received Rocephin 1 gram IM and Keflex PO. To F/U with PMD.
On December 27th 2021 I was feeling well and went to get my booster. I choose Pfizer. I received the injection at 230 pm. By 730 pm, I began to have symptoms and they worsened throughout the night and the next day ( today). Severe sore throat not relieved by water or warm liquids, swollen lymph nodes in throat and under jaw.  Difficulty swallowing, painful. I took a zyrtec for possible allergic reaction at 1230 pm and two 500 mg tylenol for pain.  Went to urgent care, had a rapid covid test ( negative). Sore throat and swollen throat lumph nodes ARE NOT listed on the CDC website as side effects. WHY NOT? NP determined it was a side effect/reaction to the vaccine.  Did not think it would need a throat culture.
Rashes on left leg/rash beginning on his left leg, above the knee going up to the groin; Itchy and has little bumps and it goes from knees to up to the groin/getting worse and it is very itching; Itchy and has little bumps and it goes from knees to up to the groin; This is a spontaneous report received from a contactable consumer (patient's wife). A 77-years-old male patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number, Expiration date, NDC and UPC number was unknown) via an unspecified route of administration on 02Apr2021 (Friday night) as dose 1, single (at the age of 77-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Apr2021, Friday night, when he came home later, patient was very itchy, had little bumps and there was a rash beginning on his left leg, above the knee going up to the groin. Now, this reaction got worse yesterday (03Apr2021, Saturday) and it was worse today (04Apr2021, Sunday). Patient 's wife went to the store and brought some Cortisone cream, but the rash does not seem to be going away. And it was still very itching on it. Patient's wife stated that it seems to be getting worse and it was very itching. Patient's wife did not think at first that it had anything to do with the injection. Therapeutic measures were taken as a result of rash and itchy and treatment included cortisone cream. The outcome of rash and itchy was not recovered and unknown for had little bumps.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
had both doses of the Pfizer BioNTech Covid-19 vaccine and had the booster too and got diagnosed with Covid today; had both doses of the Pfizer BioNTech Covid-19 vaccine and had the booster too and got diagnosed with Covid today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 08Aug2022, outcome "not recovered" and all described as "had both doses of the Pfizer BioNTech Covid-19 vaccine and had the booster too and got diagnosed with Covid today". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Aug2022) Positive, notes: got diagnosed with Covid today. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information: The caller stated he had both doses of the Pfizer BioNTech Covid-19 vaccine and had the booster too and got diagnosed with Covid today. He stated he got Paxlovid and the air conditioner is out in his house and the temperature right now is 82F in his house. He wanted to know if there are recommendations for this, especially if it gets warmer. Should it get placed in the fridge?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No additional AE; Product was administered to patient after temperature excursions; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unspecified gender. The patient's pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.  On 21-JAN-2022, the patient was vaccinated with a reported once dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (concentration, exact dose, route of administration and anatomical site of application were not reported; lot number U008180 that was verified to be a valid lot number with an expiration date reported and established as 12-MAR-2023) as prophylaxis after temperature excursions (product storage error).  The temperature excursions were reported as following: 7.4 degrees Fahrenheit (°F) with a time frame of 25 minutes, 6.4 degrees Fahrenheit (°F) with a time frame of 20 minutes and 5.9 degrees Fahrenheit (°F) with a time frame of 15 minutes. It was stated that the vaccine experienced a previous temperature excursion that were reported as: 31.3 degrees Fahrenheit (°F) with a time frame of 10 hours 28 minutes; a range between 6 degrees Fahrenheit (°F) to 14 degrees Fahrenheit (°F) with no exact temperature provided but with a time frame of 1 hour 15 minutes and then 11 degrees Fahrenheit (°F) with a time frame of 6 minutes.  No additional adverse event was reported (no adverse event).  This is one of several reports received from the same reporter. This patient was reported as patient number three out of seven.; Sender's Comments:  US-009507513-2202USA000100: US-009507513-2202USA000257: US-009507513-2202USA000275: US-009507513-2202USA000290: US-009507513-2202USA000324:
Patient was vaccinated at 3:25pm and patient was monitored for 15 minutes and  left the vaccination site at 3:40pm with no adverse reaction. Patient return to the vaccination site at 5:pm with the mother reporting patient had hives to the left side of the face.  Patient was assessed and noted hives to the left side of the face and left forearm, mild symptoms . No other reaction including swelling of the face or shortness of breath.  Patient vital signs were within normal limit.  Patient left the vaccination site at 5:15pm in a stable condition. Patient mom was advised to follow-up with the primary care physician if symptoms persists or worsens. Verbalized understanding.
Information has been received from a doctor of pharmacy concerning a 57 year old female with no drug reactions who on 23-OCT-2010 was vaccinated IM with PNEUMOVAX 23 0.5ml (lot # 667912/0933Z) on her left arm. A pharmacist reported that a patient developed 2 red welts "under her left arm" after receiving a dose. On 24-OCT-2010 the patient developed 2 red welts "under her left arm" after receiving a dose of PNEUMOVAX 23 in that same arm. The pharmacist reported that this was not at the injection site. The patient told the pharmacist that she noticed the welts on 24-OCT-2010. On 25-OCT-2010 after the original report was filled, the patient called back to say that she got a red lump about 3 inches below the welts that she originally reported. The patient took BENADRYL and the lump and the welts resolved. The patient sought medical attention by phone call. There were no laboratories diagnostics studies performed. This one of two reports from the same source. Additional information has been requested.
Patient is only 46 years old and was administered Shingrix by a visiting pharmacist on duty. The indication for Shingrix is only 50 years or older.  This was his second dose and he had gotten his first done at the doctor's office back in March 2020.
Breakthrough case admission after 2 vaccines MOderna 1/14/21 lot# 012L20A ; Moderna 2/11/21 lot# 010M20A
Began with fever 101 degrees and severe headache. Giving Motrin and to watch.
Information has been received from a consumer who reported that she heard some girls experienced hair falling after getting a dose of GARDASIL vaccine.  was unknown if the patients sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Pfizer C19 vaccine given, Patient was a staff member at facility, felt unwell, blood pressure was taken by observer, pt ultimately felt well enough to go back to her office. At some point she contacted her doctor by phone and came back to observation reporting numb tingly lips and cheeks (covered by mask). Requested a diphenhydramine 50mg, which was given at 1400. rated reaction feel as level 5. After 25 minutes asked again and rated level 1. Contacted doctor. He cleared her to go home and would follow up in 2 hours to see how she was doing.
Started with light chills.  12 hours after inoculation severe chills (during sleep).  24 hours after inoculation continued low level chills throughout day.  Body aches and general malaise.
EDD 09/27/2018-  Live MMR vaccine given to pt prior to us knowing of pregnancy.
Swelling in right knee on 3/21/19 and swelling in right middle finger on 3/23/19. No history of joint swelling.
Numb lips; My left arm where I had my vaccine like my hands felt like it was asleep; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Lot number: not reported) via an unspecified route of administration, administered in Arm Left on 04Mar2021 as dose number unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, about 20-30 minutes after the vaccine patient's lips felt numb. And then also too while lips were feeling numb, patient's left arm where patient had vaccine felt like it was asleep. It's all right that patient have had reactions to vaccines (Unspecified Vaccines) before. Then also too I was wondering if had it been reported that people started getting like rashes on their hands or other parts of their body." (Could not be clarified further if consumer had rashes or not, hence not captured as event).  Limited information was available over the call as consumer hung up abruptly. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a pharmacist referring to a 54 year old female patient with diabetes. The patient had no drug reactions/allergies. On 26-NOV-2013, the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot# J010654, expiration 17-OCT-2014, dose was not reported) intramuscularly for prevention of pneumococcal disease. Then on 17-SEP-2015 the patient was vaccinated with a second dose of PNEUMOVAX 23 (lot # L003227, expiration 13-OCT-2016, dose was not reported) intramuscularly for prevention of pneumococcal disease. "Within an hour" after receiving the second dose of PNEUMOVAX 23 on that day, the patient developed "persistent" chills, myalgia, and fatigue, for which she had visited her physician several times. Patient also experienced "chest heaviness," (unspecified date) for which she visited her physician twice on 09-OCT-2015 and 22-OCT-2015; each time, unspecified "cardiac studies" were normal. Treatment including TYLENOL of extra-strength and ALEVE was given for these events. Pharmacist reported the patient's chills, myalgia, and fatigue had not resolved, but it was unspecified whether the "chest heaviness" had resolved. Pharmacist provided the concomitant medications the patient was currently prescribed gemfibrozil, glyburide, metformin, omeprazole (manufacturer unknown), paroxetine, simvastatin (manufacturer unknown), but also stated that she could not be certain whether the patient was taking them as prescribed. Causality was not reported. Additional information has been requested.
No additional AE; Patient was administered expired PROQUAD; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported.  On 18-NOV-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD), lot # T016990, expiration date: 11-NOV-2021 (dose, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). It was confirmed that no temperature excursion was reported for the suspect vaccine. There was no additional adverse event (AE) and no product qualitycomplain (PQC).
dizzy; feels llike she has a fever; chills; sick to the stomach; A spontaneous report was received from a consumer concerning 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizzy, feels like she has a fever, chills, sick to the stomach.  The patient's medical history was not provided. Concomitant medications reported were Blood pressure pills, Thyroid meds for drug use for unknown indication.  On Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On 22 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient experienced the event(s) dizzy, feels like she has a fever, chills, sick to the stomach.  Treatment details included Nothing yet. Thinking about Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), dizzy, feels like she has a fever, chills, sick to the stomach was unknown.
nonstop fever at 100Degrees; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (nonstop fever at 100Degrees) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced PYREXIA (nonstop fever at 100Degrees). At the time of the report, PYREXIA (nonstop fever at 100Degrees) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: 100degree High.         No concomitant and treatment medication reported.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a elderly patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm (serious criteria disability) and mobility decreased (serious criteria disability). On an unknown date, the outcome of the pain in arm and mobility decreased were recovered/resolved. The reporter considered the pain in arm and mobility decreased to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. This was one of the 4 patients involving both male and female over the age of 65 years old. After receiving SHINGRIX vaccine, the patient experienced intense pain after the shot. The reporter stated that patient complained of whole arm pain with the shoulder and had decreased mobility of the arm. The patient went to emergency room for the pain and received medication but were not admitted. The reported stated that after a couple of days the pain was better, but it was very intense for 24 hours and then it started to decline. The reporter reviewed her technique and stated that she was using a new 25g needle to give the injection after removing the needle that was used to puncture the vial stoppers. The reporter noted it was disabling to them because he/she was limited in mobility of that arm. The reporter didn't have specifics of the patient at the time of this report, but would be able to get that information.
Nurse inadvertently administered 2nd dose to patient, 1 day short of her 12th birthday. Patient monitored for 15 minutes, post vaccination.
Rapid HR. Possible SOB.  BP:164/95 Pulse:98 Resp:18 Spo2=97% Recorded by healthcare worker
Per patient history only, he developed intermittent bilateral hip pain following receipt of AVA doses #1-5 from 1999-2000; denied hx trauma or overuse; did not recall whether pain was exacerbated with subsequent doses; did not recall presence of large local injection site reaction or any other systemic symptoms; pain remains intermittent/persistent to date; symptom has not yet been medically evaluated.  Symptom: Bilateral Hip Pain (chronic intermittent).
Information has been received from Sanofi Pasteur (manufacturer control # E2015-07945) as part of business agreement on 10-JUL-2015. Case received from Health Authority (case n. 317064) on 08 and 09-JUL-15. Case initially reported by other health professional. Case medically confirmed. An 11 year old female patient was vaccinated on 27-JAN-15 with the second dose of GARDASIL, lot batch n. K003185, expiration date-31-MAY-2016) IM. On 08-JUL-15 the mother referred that since she started sleeping with her daughter (23-JUN-15) she observed her having nocturnal spasms and tremors. The patient was evaluated by a neurologist, investigations were performed (NOS), excluded the presence of an epileptic disorder. Other investigations are pending. The outcome is not recovered. The case is closed.
9/10/14 8:00am Patient came in with mother to report and show left upper arm redness and swelling. Pt. c/o mild pain and itching since 9/9/14 am. Dr. saw pt. and prescribed and given diphenhydramine 25mg PO qd x 5 days. Instructed pt. to apply warm compress & come back tomorrow on 09/11/14 to see Dr.
Patient received morderna vaccine on 12/30/20 and 1/26/21. COVID positive on 5/10/22. This was a 96-year-old frail, retired who was brought in for further  observation after presenting to the emergency room at the insistence of his  wife because of increasing weakness and concern on her ability to adequately  care for his healthcare needs at home.  Details are as outlined in the history  and physical.  In the emergency room, he did not appear in any acute distress  per the ER staff, but he was found to be COVID positive.  His C-reactive  protein was normal.  His procal was normal.  There were questionable  atelectatic versus infiltrate changes in both the left lower lobe and the  right upper lobe, but he was saturating good on just 2 L O2 per nasal cannula  in no respiratory distress.    He was admitted for overnight observation.  He very quickly felt better with  cautious IV hydration, although he did not look horribly dehydrated.  His BUN  and creatinine were 19 and 1.1 respectively, although his urine specific  gravity was mildly elevated at 1.024.  IV fluids were discontinued the next  day.  He remained afebrile.  His urine was otherwise unremarkable.  His  Accu-Cheks remained okay other than mild glucose intolerance.  He actually was  requesting to go home the following morning.  He felt his wife was blowing  out of proportion his degree of weakness, but in talking with her, the 2  caregivers that were there at the time were not able to get the patient up from a  seated position and even move from the bed to the chair and she was just  concerned that with a single caregiver there at night that if the patient needed  additional help that she would not be able to meet his needs, hence the ambulance call on admission.    All that being said, he was seen by the therapist.  He looked good, felt good.   We discontinued O2 and he was saturating good.    The chest findings remained benign on exam.    He was not administered any other treatment protocols given his benign course.   He was discharged in stable condition on the 2nd hospital day with plans for  followup in our office in the next 2 weeks. Discharged on 5/11/22