chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist, concerning a 40 year old female patient with human immunodeficiency virus (HIV) disease as concurrent condition and no previously drug reactions or allergies. The patient's concomitant medication included dolutegravir (+) rilpivirine (JULUCA). On 22-SEP-2017, 26-APR-2018 and on unspecified date, the patient was vaccinated with RECOMBIVAX HB 40 micrograms injection, intramuscularly (dose, anatomical location, lot numbers and expiration dates were not provided) for prevention of hepatitis B; the patient completed a three-dose series of RECOMBIVAX HB, however pharmacist could not clarify whether these were the dates of administration of the first and second doses, second and third doses, or first and third doses. Pharmacist also did not clarify whether the patient was on dialysis (indication for this dose). On an unspecified date in 2018 (reported as: "recently"), the patient had titers drawn which showed the patient was negative for immunity to hepatitis B (hepatitis b surface antibody negative). At the time of report, the patient was not recovered from hepatitis b surface antibody negative and she had not been treated from the adverse event. The causal relationship between the hepatitis b surface antibody negative and  RECOMBIVAX HB was not provided.
Two days following vaccine, patient experienced N/V and right lymphadenopathy (on same side as injection) which continued for two additional days.  On Day 5, patient experienced neck and facial swelling, rash, itchy mouth, throat tightening,  and difficulty breathing following lunch (chicken with cashews, no prior food nor medication allergies nor prior symptoms with any tree nuts nor peanuts nor soy). Symptoms improved with 50 mg diphenhydramine, but swelling continued, administered corticosteroids at urgent care facility and continued Medrol dose pack. Food allergy testing scheduled for mid-May.
Patient stated that 3 days after getting the Pfizer vaccine that she blew her nose and had clots.  This caused her concern and so she went to the ER seeking medical care. They ran test and ruled out other possibilities of what could have caused the clots  and came up with the vaccine as the main cause of the clots.  She stated that they did a brain scan and said that she was fine.  Her md is aware of what happened and wanted her to receive the second shot which was given today on 9/26/21, but since she had COVID already as well that she will not need to get a 3rd dose.  We have only given her vaccine and have not filled any regular medications for her so we do not have her medical md on file.
Patient presented requesting COVID moderna bivalent booster. However, patient handed vaccinator wife's influenza registration paperwork. Vaccinator confirmed patient name/DOB and flu vaccine. Patient confirmed himself as wife's name, DOB and that he wanted flu. Patient received flu dose. Only after patient received flu dose did patient say no, that is not me (despite previously confirming this being his information). Patient had received flu dose 2 weeks before. Patient observed, no adverse side effects, just did not receive requested vaccination due to patient giving wrong registration form and then confirming wrong information.
Pain in left arm shoulder.  Employee felt it was placed to high, felt crunching, has had burning, aching since time of vaccination.
Night waking Swelling in hands, feet and ankles. Legs not weight baring without pain
This patient's left deltoid was swollen, red, warm to the touch, from the shoulder to the elbow to the entire upper arm. She was seen in the ER and prescribed Benadryl on 02/06/01. ON 02/07/01, the patient was seen in the office and given steroids and warm compresses. The local reaction is not resolved as yet on 02/08/01.
Itching; joint pain; hot flashes; body pain; heavy breasts; throbbing all over; This is a spontaneous report from a contactable healthcare professional, the patient. A 65-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Mar2021 at 10:00(at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included drug allergy (quinolone) and hashimoto's disease. Concomitant medications included levothyroxine sodium (SYNTHROID), losartan (MANUFACTURER UNKNOWN) and pravastatin (MANUFACTURER UNKNOWN) on unknown date for unspecified indication. The patient previously took ciprofloxacin (CIPRO) on an unknown date and for an unknown indication and experienced drug allergy. 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 other vaccines within four weeks prior to the COVID vaccine. On 05Mar2021 the patient experienced itching, joint pain, hot flashes, body pain heavy breasts, and throbbing all over. The adverse events resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event itching, joint pain, hot flashes, body pain, heavy breasts, and throbbing all over was not recovered at the time of this report.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Red rash in left leg/rash on both legs; Turned dark; This spontaneous case was reported by a physician and describes the occurrence of RASH ERYTHEMATOUS (Red rash in left leg/rash on both legs) and RASH (Turned dark) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hyperlipidemia, Chronic kidney disease (CKD 3), Vitamin D deficiency and Thrombocythemia. Concomitant products included DICLOFENAC for Arthritis, SIMVASTATIN for Hyperlipidemia, AMLODIPINE and IRBESARTAN (AVAPRO) for Hypertension, VITAMIN D NOS for Vitamin D deficiency.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash in left leg/rash on both legs) and RASH (Turned dark). The patient was treated with CLOBETASOL PROPIONATE at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red rash in left leg/rash on both legs) and RASH (Turned dark) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Medication was high blood pressure medicine as provided by the patient. Treatment information include OTC tropical cream.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up received on 10 May 2021 contain information: Patient  demographic details updated. Medical history was updated, Concomitant products was updated. Event onset date and outcome was updated.
This spontaneous report was received from a 37 year old female patient regarding herself. The patient has cipro and penicillin allergy. On 25-JUN-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, batch# not reported) because according to an unspecified physician, an unspecified blood test indicated that the patient had insufficient immunity against the varicella virus and the patient was preparing to undergo unspecified fertility treatment on an unspecified date. No concomitant medications were reported. On 12-JUL-2013, the patient noticed being late in her menstrual cycle. She was still waiting for her cycle to begin and was concerned because it had never been late before. No treatment was given for the event. She took an unspecified drug store pregnancy test on an unspecified date after noticing that she was late in beginning her cycle and the result was negative. But her late cycle was causing her to question the negative result. Patient sought medical attention. She called the office of her physician about this adverse experience and she was still waiting to hear back from her physician for clinical advice. According to the prescribing information, the adult indication is two injections, but the consumer did not specify whether or not the shot she received on 25-JUN-2013 was given as part of a two-dose series. The outcome of being late in her menstrual cycle was not recovered. Additional information has been requested.
Pt called to say that she had hip pain and lumps on her left calf. Seen by MD on 6/5/00 and he indicated that it could have been a reaction to vax. Medrol iniated.
abdominal Rash; This case was reported by a consumer via call center representative and described the occurrence of rash in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2018).   In February 2019, the patient received the 2nd dose of Shingrix. In August 2019, between 5 and 7 months after receiving Shingrix, the patient experienced rash. The patient was treated with valaciclovir hydrochloride (Valtrex) and prednisone. On an unknown date, the outcome of the rash was resolved with sequelae.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: The patient reported that following the vaccinations in August2019, she developed an abdominal rash and went to the emergency room. She was prescribed prednisone and valtrex and the rash resolved several days later. Time passed and in April 2020, she developed similar abdominal rash, again visited the emergency room and was prescribed prednisone and valtrex, and the rash resolved. Her most recent outbreak was in July 2020, She visited her healthcare professional, who scheduled an appointment for her to see a dermatologist. No hospitalizations occurred for any of the visits. The reporter consented to follow up.
Pain on a scale of 1-10 rated a 4; This is a spontaneous case ates initially received from a other non-health professional on 26-Aug-2019, concerning a female, elderly patient.    The patient's medical history included open heart surgery and heart valve replacement that contained a plastic component, multiple allergies including latex allergy, joint pain, muscle pain and walking with cane.   The patient's past medications included Afluria Trivalent (influenza vaccine) and Afluria Quadrivalent (influenza vaccine).The patient's concomitant medication included Tylenol (paracetamol) for unknown indication. The patient reported taking ten drugs but did not wish to list them all.   On an unspecified date in 2018, the patient was administered Afluria [influenza vaccine, batch number, route of administration, anatomical location, expiry date: not provided] for influenza prophylaxis. The patient was unable to verify if this vaccine was Afluria trivalent or quadrivalent.   Within half hour after vaccination, the patient experienced pain. On a scale of 1-10, the patient rated a 4. The pain lasted 3-4 days and as reported, if the patient ate something which she should not, she got the same pain. The patient did not receive any treatment.   The reported did not provide causality assessment.   This case is linked to 201904505, concerning the same patient.  Non-significant follow-up received from other non-health professional on 09-Oct-2019: Additional agency reference number 'SEQ19-02302' added. No changes in narrative.   Company comment: The patient experienced pain, half an hour after vaccination with Afluria vaccine (not reported whether it was trivalent or quadrivalent). Chronology is plausible. Reportedly, the pain lasted 3-4 days and if the patient ate something which she should not, she got the same pain, which confounds causality. The patient's medical history of heart valve replacement, joint pain, muscle pain, advanced age and multiple concomitant drugs (not specified) also may have contributed to development of the event. More information regarding event details and concomitant medications is needed. Based on provided information, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reporter's Comments: The patient experienced pain, half an hour after vaccination with Afluria vaccine (not reported whether it was trivalent or quadrivalent). Chronology is plausible. Reportedly, the pain lasted 3-4 days and if the patient ate something which she should not, she got the same pain, which confounds causality. The patient's medical history of heart valve replacement, joint pain, muscle pain, advanced age and multiple concomitant drugs (not specified) also may have contributed to development of the event. More information regarding event details and concomitant medications is needed. Based on provided information, causal role of the suspect product cannot be totally excluded and is assessed as related.
Headache, CoughWheeze, Bodyaches, Phlem in back of throat, tiredness Narrative:  Continue to monitor for acute changes.  Seek medical attention as needed
have not received the second dose yet.; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 29th June 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient had not received the 2nd dose of Shingrix, which led to incomplete course of vaccination.  The VAERS details reported for 1st dose of Shingrix. The reporter consented to follow up.
The issue is continued abnormal mensuration.  I had my usual mensuration, 5 days prior to vaccination, Monday, March 29, through Friday, April 2.  My period had completed by the morning of April 3.  I had my first vaccine shot at approximately 10:30am April 3, 2021.  On Monday, April 5, I began slightly menstruating mid-afternoon, increasing into the day and evening, continuing through the day Wednesday, April 7.  Approximately 1-2 tablespoons per 12-hour period (I use a mensural cup, and as a result can track the same).  Period was gone Thursday, April 8 and thereafter, until Monday April 12.  On Monday, April 12, once again began menstruating in the evening, continued through Tuesday, April 13, and into today, April 14, 2021.  Yesterday and today, it is enough that a mensural cup is necessary.  The April 5 through April 7, and April 12 through today, April 14 (and possibly beyond) is abnormal mensuration for my cycle.  My mensuration occurs for approximately 5 days and full cycle length is typically 21-25 days.  I do not have break through bleeding between mensuration.  I am not on hormonal birth control and have not been for approximately 2.5 years.  Mensuration has been the same cycle as noted above during that 2.5 year period (with one exception when the cycle was 40 days, but still no breakthrough bleeding).
Back pain; Neck pain; Head pain; Nausea; Fever; Feel warm almost 24 hours out; This is a spontaneous report from a non-contactable consumer, the patient. A 23-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via unspecified route of administration in the right arm on 26Mar2021 at 11:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) for treatment of adverse event. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via unspecified route of administration in the right arm on 05Mar2021 at 11:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient had just sore arm after first dose. The patient was known allergic to sulfa medicines, amoxicillin, eggs, milk, cheese, wheat, gluten and ragweed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 21:00, the patient experienced back pain that made it difficult to stand which spread to head and neck. Within couple of hours, the patient felt nauseous and felt as if she had fever. The patient reported that she never registered a temperature higher than 99.0 F. she experienced this for 12 hours before the pain stopped. The patient still had slight nausea and feel warm almost 24 hours out, but no where near as bad as she did before. Therapeutic measures were taken with ibuprofen for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events, back pain, neck pain, head pain ,nausea, feeling warm and fever was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
patient fainted following administration of each vaccine. Following the second vaccination (fluzone influenza) into the left arm, patient began to seize for about 6 seconds. Patient stated prior to vaccines that he passes out every time he get a vaccine. Following the seizure, patients parents stated that he has had seizures in the past but never following a vaccine. I, the administering pharmacist, offered to call 911 and made sure patient was safely positioned. Parents declined my offer to call 911 and stated that he was fine. Monitored patient after the administration until he was okay to leave. Parents took him and he walked out of the store about 5 minutes following  the following.
Moderna COVID-19 Vaccine EUA Afternoon after receiving the vaccine on 12/22/20, developed arm pain at injection site, 'can't keep eyes open' fatigue and sore throat.  12/23/20 symptoms were continued arm pain, manageable fatigue, and worsening sore throat with new drainage and sinus pressure.  12/24/20 arm pain noted to be much improved as with fatigue & sorethroat- sinus issues worsening. 12/25/20 sinus issues continuing but less severe.  No fever at any time during past 3 days.
This spontaneous report as received from a 62 years old female consumer refers to herself. The patient did not have drug reactions or allergies. The patient was vaccinated with a dose of ZOSTAVAX (lot number not provided) in November 2009. No other co-suspects were reported. Concomitant medications included "muscle relaxers". In November 2009 the patient got the shot injection on the joint of the left shoulder. She felt the shot going towards her neck and it was followed by cramping and burning ever since then. Treatment (unspecified) was given for adverse event. The outcome of adverse events was unknown. It was unspecified if the patient had sought unspecified medical attention. Additional information has been requested.
Fever: range 100.2 to 103.5 starting on 11/2/07 thru 11/4/07. Motrin and Tylenol given. Hives: 11/3 - 11/4/07. Benadryl given. Once seen by RN/NP, Atarax syrup and hydrocortisone prescriptions given. Sore throat: 11/2/07. Rocephin shot given on 11/3/07 by RN. Azithromycin prescription given by NP.
pain in bottoms left side and pain in both shoulders; pain in arms when lifting up arm and pain in both shoulder; Pain in bottoms left side; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in bottoms left side and pain in both shoulders), MYALGIA (pain in arms when lifting up arm and pain in both shoulder) and MUSCULOSKELETAL PAIN (Pain in bottoms left side) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. U36B21A and 022C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, METOPROLOL, AMLODIPINE and ROSUVASTATIN for an unknown indication.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced MUSCULOSKELETAL PAIN (Pain in bottoms left side). On an unknown date, the patient experienced ARTHRALGIA (pain in bottoms left side and pain in both shoulders) and MYALGIA (pain in arms when lifting up arm and pain in both shoulder). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency; IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at an unspecified dose and frequency and MELOXICAM (oral) ongoing since an unknown date at a dose of 7.5 mg. At the time of the report, ARTHRALGIA (pain in bottoms left side and pain in both shoulders), MYALGIA (pain in arms when lifting up arm and pain in both shoulder) and MUSCULOSKELETAL PAIN (Pain in bottoms left side) had not resolved.            Concomitant medications included hydrochloro as reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: TCR received on 9-JUN-2021 contains no new information. On 14-Jun-2021: Follow up received on 14-JUN-2021 contains Meloxicam 7.5 mg as new treatment drug
Vertigo; Body ache; Nausea; She felt funny; 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 83 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "She had a panic attack before the vaccine" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine (she was sick for 10-12 days after receiving the flu shot.), reaction(s): "Feeling sick". The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "Vertigo"; PAIN (non-serious), outcome "unknown", described as "Body ache"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "She felt funny".   Additional information: The patient reported that she had an appointment on the 27Apr for 2nd dose of the pfizer covid vaccine. But, scared to get the vaccine again. Stated that after she received the first dose, she felt funny, nausea, body ache. She had a panic attack before the vaccine. She also experienced vertigo however unclear if vertigo was after the flu shot.  Caller asked that were her side effects normal/reported with the covid vaccine.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I was diagnosed with Bell?s palsy. Left side facial paralysis. These symptoms lasted about 3 weeks during treatment
pt recv vax 16JUL93 & SEP93 pt exp back pain, abd pain, & transient nausea & dizziness;pt began to take pain med occasionally;@ time of report pt taking med;MD could not determine the cause of sx but pt felt r/t vax;