chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Have deep calf pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Have deep calf pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Have deep calf pain). At the time of the report, PAIN IN EXTREMITY (Have deep calf pain) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Relevant concomitant medications were not reported.  It was reported that the patient had deep calf pain and it has been 5 months since the patient got the first dose of Moderna COVID-19 vaccine.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-624231 (Patient Link).
Pfizer-BioNTech COVID-19 Vaccine EUA given to RD on 12/16 @ 12pm. Loss of feeling in right arm started @ 4pm & lasted until end of day on 12/17, along with muscle weakness & migraine. All symptoms resolved by 12/20 & she felt great.
fever; eyes hurt; stuffy nose; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), EYE PAIN (eyes hurt), NASAL CONGESTION (stuffy nose) and HEADACHE (slight headache) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PYREXIA (fever), EYE PAIN (eyes hurt), NASAL CONGESTION (stuffy nose) and HEADACHE (slight headache). At the time of the report, PYREXIA (fever), EYE PAIN (eyes hurt), NASAL CONGESTION (stuffy nose) and HEADACHE (slight headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Body temperature: 100.3 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided. Patient reports for the last 10 days my temperature has been in the 97 degrees range. Currently it is 100.3 degrees.
This spontaneous report was received from a 79 year old female patient who refers to herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 01-JUN-2017, the patient was vaccinated with PNEUMOVAX 23 injection, intramuscularly (dose, lot# and expiration date were not reported) for active immunization for the prevention of pneumococcal disease. On 09-SEP-2017, the patient experienced pneumonia and was hospitalized. Approximately in September 2017, the patient experienced cough and stated that she was still coughing after 2 kinds of (unspecified) antibiotics. At a time of this report (reported as "still"), the patient did not recover from cough. The outcome of pneumonia was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported. Upon internal review, the event of pneumonia was considered to be medically significant.
Warm Autoimmune Hemolytic Anemia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Nov2021 at 16:30 as dose 3 (booster), single (Lot number: 32030BD) at the age of 36 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0158), administration date: 09Apr2021, when the patient was 36-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Dose Number: 2, Batch/Lot No: EW0173), administration date: 05May2021, when the patient was 36-year-old, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: WARM AUTOIMMUNE HAEMOLYTIC ANAEMIA (hospitalization, medically significant, life threatening) with onset 25Nov2021, outcome "not recovered", described as "Warm Autoimmune Hemolytic Anemia". The patient was hospitalized for warm autoimmune haemolytic anaemia (hospitalization duration: 5 day(s)). The event "warm autoimmune hemolytic anemia" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of warm autoimmune haemolytic anaemia with blood transfusion and medications. The patient did not have covid prior to vaccination and tested positive post vaccination. The patient had no known allergies.
R10.9 Unspecified abdominal pain; This spontaneous report was received from physician via medical records and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 27-JUN-2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (lot #, expiry date, route of administration, and anatomical location were not provided).  On 10-DEC-2018, the patient experienced unspecified abdominal pain (R10.9). On 28-DEC-2018, the patient was vaccinated with an additional dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (lot #, expiry date, route of administration, and anatomical location were not provided).   At the time of reporting, the outcome of the event unspecified abdominal pain was not reported.   The causal relationship between the event of unspecified abdominal pain and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Participant was not able to make her appt because she was ill. Cold/Sinus infection on Friday, 2/1/2002. However, she is still ill and going for chest x-ray on 2/5. Postmenopausal has started vaginal bleeding.
Patient received Pfzier Vaccination on 4/10/2021 at the health center. Patient came to clinic on 08/04/2021 for his 1st Covid vaccination and had chosen the Moderna vaccine. Patient stated  that this will be the 1st Covid shot he had gotten.  Looked into database and noticed that patient has received the Pfizer in April 2021. Patient was contacted to inform him that he doesn't need to get another Moderna vaccination.
Redness, swelling to (L) thigh on 4/5/12. (+) pain. Gave Ibuprofen PRN. Also gave TYLENOL with Codeine (had leftover from previous need).
Pt reported nausea and feeling like passing after getting the vaccine.  Pt sat down on the floor.  BP 104/77, HR 65.  Before discharge: BP 123/87, HR 75
This spontaneous report as received from a pharmacist and refers to an elderly male patient of unknown age and gender. Information regarding the patient's medical history and concomitant medications was not provided. The pharmacist reported that on 24-MAY-2012 the patient was vaccinated with a dose of PNEUMOVAX 23, then on 08-JAN-2016, the patient received a dose of PREVNAR 13, and then, on 12-JUN-2017 the patient received another dose of PNEUMOVAX 23 for prophylaxis. Strength, dose, route, lot number and expiration date for all the administered vaccines, were not reported. The pharmacist reported that the patient was over 65 years of age when he received all of these doses.
Myalgia, Fever, injection site pain anf fatigue with both doses for 72 hrs- rest with second dose Narrative:  Other Relevant History:
Extensive swelling to right thigh and right proximal lower leg. Mild redness distal to thigh on day 3 resolved on day 4. No fever, no limping, well appearing child. Elevated CK, CRP, and ESR. CT demonstrates fasciitis.
Muscle aches, fever, itching of feet, sweating, hives (head to toe).
This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUAD for prophylaxis. On an unknown date, the patient received SHINGRIX and FLUAD. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivering, fever, fatigue and gastrointestinal upset. On an unknown date, the outcome of the shivering, fever, fatigue and gastrointestinal upset were recovered/resolved. It was unknown if the reporter considered the shivering, fever, fatigue and gastrointestinal upset to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and FLUAD into arm. The pharmacist reported that she had given SHINGRIX to many people and followed up with each recipient. Additionally, she had given 2 patients FLUAD at the same visit as SHINGRIX (in opposite arms). The pharmacist stated that, most of the patient's reported shivering, gastrointestinal (GI) upset, fatigue or low-grade fever which was mild and resolve within 24 hours. The pharmacist stated that these 2 people did not report any different or more severe side effects compared to those who did not receive FLUAD and got SHINGRIX alone. The pharmacist said that, she did not feel like these adverse events were worthwhile to report, as they were all mild and self limiting. The patients that received FLUAD on the same day did not experience worse symptoms. This case has been linked to the US2018GSK177718 (unspecified number of patients who received only SHINGRIX) and US2018172531 (the 1st patient who received SHINGRIX and FLUAD both), reported by the same reporter.
"COVID arm":  about 5 or 6 days after receiving the injection, a rash appeared, with itching and minor swelling.  This lasted 2-3 days.
Skin started peeling on palms and fingers of both hands from Sunday PM.  No pain, no itching.  Almost back to normal by Tuesday.  By Wednesday, it was gone.  Very minor side effect with no discomfort.  Just thought I'd report it.  Attached a picture.
Bruising at and below injection site. Some swelling. Instructed to take BENADRYL and call family MD if not improved by 1/6/11 (tomorrow).
Patient received vaccination while under age 18.  EUA for Moderna vaccine is 18 years old or greater.
A few hours after receiving HAVRIX, the patient started to develop hives. The hives started in her groin and spread to upper extremities and ankles. She was given Benedryl at home and woke up with a few mild lesions on her ankles. She denied any tongue swelling or shortness of breath.  Patient was seen the next day by PA-C and was instructed to continue Benadryl every 4 hours as needed.
CLIENT REPORTS FEELING DIZZY, NAUSEOUS AFTER VACCINATION, WITH LOSS OF CONSCIOUSNESS, PRIOR TO FALLING OUT OF CHAIR, CLIENT ASSESSED, ALERT AND ORIENTED X3, RESP EVEN AND UNLABORED, SKIN PALE/GREENISH COLOR, VITAL SIGNS STABLE, NO ACUTE DISTRESS, VISIBLE INJURY NOTED TO RIGHT LATERAL SIDE OF FACE, NO BLEEDING, NEURO INTACT,  REFUSED EMS, ADVISED TO FOLLOW UP WITH PCP; ER FOR ANY NEW OR WORSENING SYMPTOMS, PROVIDED WATER, GATORADE, CRACKERS, ICE PACK, OBSERVED FOR AT FACILITY FOR 1 HR, CONDITION IMPROVED PRIOR TO DEPARTURE
pt recv vax 21JUL97 & 10 days later mom describes pt as being unable to walk when placed on feet, being unable to stand on own w/weak & limp legs, but nl arm, motion & strength;episode resolved slowly p/5hr w/no intervention;
Mild Fever (max 100.3), Cough, Fatigue, Runny nose, Congestion, Headache, Dizziness, Nausea. Symptoms started within 3 hours of receiving vaccine.  Symptoms continue still today 12/27/20. Taking Tylenol and ibuprofen to control the fever and afrin nasal spray for congestion.
Hives and itchiness on arms, swollen tongue, tightness in throat, trouble breathing and swallowing all within 30 to 45 minutes of receiving vaccine. Took 50 mg of BENADRYL which reduced symptoms. Received a steroid shot to further reduce the skin reaction.
I was in the kitchen fixing food when I started having pain in my back, it went up into my shoulders. It was an intense pain. I became extremely weak, I started vomiting, my blood pressure was 196/117 BP, and I was sweating. My grandson called 911 and  I was taken to the hospital Cardiologist said heart was fine. I did NOT have a heart attack. He thinks it is due to the vaccine. Advised that I take the second shot.
This spontaneous report was received from a company representative. The field representative state that the doctor indicated all three female patients were administered PNEUMOVAX 23 at an unknown date all three patients developed swollen lymph nodes, flu symptoms and injection site reactions. All fields apply to all three patients. No other co-suspects were reported. No concomitant medications were reported. The outcome of swollen lymph nodes, injection site reactions and fly symptoms is unknown. The relatedness for swollen lymph nodes, injection site reactions and flu symptoms is unknown for PNEUMOVAX 23. No further information is available.
Information has been received from a nurse practitioner concerning a 17 year old female who on 16-NOV-2006 was vaccinated in the left arm with a first dose of Gardasil. On 16-NOV-2006 the patient experienced left hand numbness. The patient recovered after a couple of minutes. On 24-JAN-2007, the patient was vaccinated in the left arm with a second dose of Gardasil. On 24-JAN-2007 the patient experienced left hand numbness. The patient recovered after a couple of minutes. On On 16-JUL-2007 (previously reported as 20-JUL-2007),  the patient was vaccinated in the left arm with a third dose of Gardasil. On 21-JUL-2007 the patient woke up with the numbness in her left hand. The patient had no ascending numbness, no soreness, no local tenderness nor swelling.  The patient sought unspecified medical attention. A "pen prick test (villianbrea test)" was performed. The patient was diagnosed with brachial plexopathy. The patient's brachial plexopathy persisted. On an unspecified date, the patient recovered.  Additional information is not expected.
Left arm upper site of administration, swollen with erythema spreading from shoulder down to elbow joint warm to touch, blistering with crustiness and clear fluid oozing. Hx of eczema itching site and c/o pain.
Had significant arm pain and low grade fever/chills for two to three days after vaccine. On day 4 developed warm, almost circumferential rash about 1-2 inches below the site of the injection (see picture) that lasted for an additional 2-3 days, treated with BENADRYL. Macular, confluent rash, no pain, had warmth, no axillary lymphadenopathy. Fully resolved by day 7 after injection. I have never had either the degree of pain at injection site on the rash with any other vaccine prior to this.
Pt received vaccine 10/28 and complained of "severe pain" later in the day. The pharmacist on duty recommended APAP for pain. Rph checked in on patient next day and was told issue resolved. Now on 11/5/14 pt's husband contacted us saying pain persists.
Pt recvd 2 doses of Engerix-B 15APR91 & 15MAY91 & devel sinus infection type sx lasing 1 wk;
12/31/2020 to 01/03/2021 = Fever of 39°C for 3 days (12/31/20 to 01/02/20); Chills; Joint Pain; Severe Fatigue; Headache; Muscle Pain; Note: NO RESPIRATORY SYMPTOMS.   01/04/2021 = No fever; Continued Severe Fatigue; Continued Headache; Continued Joint Pain; Note: all other symptoms resolved (see above / listed previously).
This case was reported by a nurse via a sales representative and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On an unspecified date on or prior to 17, January 2007, the subject received unspecified dose of Fluarix (0.5 ml, unknown, right arm). On an unspecified date after vaccination with Fluarix, the subject experienced injection site pain, joint stiffness and unable to raise arm. At the time of reporting the outcome of the events was unspecified.
felt tired; 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 78 year-old female patient received bnt162b2 (BNT162B2), administration date 09Feb2021 (Batch/Lot number: unknown) as 1st dose, single and administration date 04Mar2021 (Batch/Lot number: unknown) as 2nd dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "felt tired". Additional information: it was reported that after the first dose of the vaccine her and her husband felt tired afterwards. Caller does not think it was attributed to the vaccine and states it was because they got up at 05:00 to go have the vaccine done. Otherwise had no side effects from either dose. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021310097 same reporter/drug, different patient.;US-PFIZER INC-2021310098 same reporter/drug, different patient/event.
Information has been received from a physician concerning a 70 year old male who on 29-JUN-2007 or 02-JUL-2007, was vaccinated SC with a single dose of Zostavax (Oka/Merck).  It was reported that immediately after vaccination the patient developed swelling and rash at injection site.  The patient was observed in the office and no treatment was required.  At the time of report the patient had recovered.  A product quality complaint was not involved.  Additional information has been requested.  This is one of several reports received from the same source.
Hospitalized in Jul2020 for this with double pneumonia; Hospitalized in Jul2020 for this with double pneumonia; left lung collapsed; for another chest X-ray to see the damage that COVID has done; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient (age at vaccination was reported as "in her 50s" received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date were not reported) and pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (Manufacturer unknown, lot number and expiration date were not reported); both via unspecified routes of administration on unspecified dates at a single dose for immunization. Medical history included pneumonia for 7 times. Family history includes father has heart disease; has a defibrillator; pacemaker and celiac disease. Cancer runs in her family. All of her sisters have had breast cancer, all of her cousins have had breast cancer, all 3 of her aunts died of breast cancer; and another aunt died of leukemia myeloma acute. It was reported that the patient was hospitalized in Jul2020 for double pneumonia, left lung collapsed. Because had double pneumonia and collapsed lung she has to see a pulmonologist for another chest X-ray to see the damage that COVID has done (pending clarification). It was mentioned that the patient had pneumonia like 7 times in the past so she is susceptible. Because of this history she has gotten the pneumonia vaccine and Prevnar 13 vaccine. Prevnar 13 when she was too young, in her 50s like 4-5 years ago because had pneumonia so many times. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant product use was reported. The reporter who was an HCP reported an excursion about a month ago, at the time the reporter didn't asked for a stability report but now the reporter had been asked to send the stability report. The patient didn't had any adverse events post injection. The reporter stated that they were yet to receive the temperature stability report for this excursion that occurred on 10-Mar-2022. The transmission date reported as 15-Mar-2022. No treatment information was provided.
This spontaneous report was received from an office manager referring to a 4 month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 30-NOV-2017, the patient was administered a dose of improperly stored ROTATEQ lot # M044397, expired on 20-JUN-2018 or lot # N003984, expired on 19-NOV-2018 (the specific lot number administered was unknown by reporter), orally, for prophylaxis (strength was not reported). The vaccine was stored at or above a temperature of 32°F up to 35°F (35.4°F) for 45 minutes. No previous temperature excursions neither adverse effects were reported. The call was because of a data logger.
Pt. received his 2nd dose of the Moderna COVID-19 vaccine on 2/3/2021. On 2/10/2021; Pt.wrote an email to staff indicating he had received his vaccine on 2/3/2021 and had since been experiencing "sharp stabbing pain" in his shoulder with movement. Pt indicated in his email the pain felt similar to a rotator cuff injury he had obtained to his other shoulder in high school.  Pt. reported he felt like the vaccinator injected the vaccine higher than appropriate which is why he is experiencing pain.  RN called Pt to discuss further. Pt. stated the injection site is a yellow bruised color with swelling above it. Pt. states at times he feels like the pain is getting better but then it always seems to return. Pt. denied fever or other symptoms.RN advised Pt. to call his PCP for evaluation as soon as possible.   Documentation was reviewed. VAMS did not have the vaccinators name in the system accurately. It sited a vaccinator who was not in clinic on 2/3/2021. Upon investigation from paperwork, Pt.card confirmation, and scheduling assignments the vaccinator was identified as Registered Nurse  License # 10.E37725 Exp date: 6/30/2021.