chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received from nurse on 07-Dec-2017, concerning a 50-year-old, adult male patient. The patient's medical history and concomitant medications were not reported. The suspect vaccine FLUCELVAX QIV underwent temperature excursion for about 30 minutes and lowest temperature was 34.7-degree F (out of the recommended range). On 01-Dec-2017, the patient was administered with FLUCELVAX QIV which underwent temperature excursion (batch number: 195250, expiry date: 30-Jun-2018, dose, route of administration and anatomical location: not reported). The reporter assessed the events as non-serious. Case correction received with IRD 07-Dec-2017: Added classification as "special case with no AE" in the general tab. Updated expiry date of suspect vaccine as 30-Jun-2018 (in the product tab). The narrative was amended accordingly.
Approximately 30 minutes after administration, patient reported swelling and erythema of L arm, starting with injection site (vaccine given in L deltoid). Swelling and erythema then spread to R arm. She developed erythematous rash across chest and nausea.  PO benadryl, PO zofran,  and IM solumedrol injection were administered in clinic.  Patient was monitored for > 1 hour. Swelling, rash, and nausea resolved. Vitals stable. Patient discharged home. She returned to clinic the next day for nurse visit for follow up and reported she was feeling well.  Tdap vaccine was also given in clinic the same day (opposite arm) but patient states that symptoms started before administration of Tdap and symptoms started at injection site for Flulaval vaccine. She also reports previous history of reaction to flu vaccines. She also reports history of egg intolerance and has been using protein powder with egg.
Initially, the affected area was very painful for 4 days. Patient noted that it has become raised, red, warm to the touch and sensitive 4/29- f/u call no answer
Expiration date for the lot# had been extended, vaccine remained frozen until date of administration. Vaccine was given 2 days past expiration date.  Moderna consulted and deemed the vaccine viable so revaccination is not necessary.  No adverse side effects were reported by patient.
A few hours after getting the shot, went home and took a 3 hour nap - I never take naps!  Have felt a little under the weather - sneezier than normal, more tired than normal since.  My wife, who got her shot at the same time, went to the doctor today for respiratory issues, was told it was a virus of some sort, not H1N1 or flu - but was not tested.  We both have had more sinus congestion than normal since the shots, and occasional dry cough for me, consistent for her.
Medication error-child initially received 3  vaccines.  The ProQuad #1131R Merck was noted to be expired (3/13/2007) after administration.  Childs mother was notified of this while still at the clinic.  Informed her dose would not count since expired and she was given the choice to re-immunize her son same day or return in a month.  She requested he receive the 2nd ProQuad the same day and it was given about 2 inches above first vaccine on the same arm.
Strong Headache for 12 hours , Muscular and joint pain all over the body for 24 hours, Localized pain in the left arm for +24 hours, Sickness,
This spontaneous report as received from a nurse refers to a 41 year old male patient. The patient was vaccinated with a dose of PNEUMOVAX23 (lot number, expiry date, route and dose were not reported) twice on an unspecified dates but still had not seroconverted. No concomitant medications were reported. The outcome of the event was unknown. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 73-year-old male patient who received SHINGRIX for prophylaxis. On 16th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th December 2018, 2 days after receiving SHINGRIX, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was not recovered/not resolved. It was unknown if the reporter considered the tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. The patient planned to follow-up with his physician on an unknown date. The reporter consented to follow up.
red, swollen knot appeared at the injection site last night; red, swollen knot appeared at the injection site last night; red, swollen knot appeared at the injection site last night; the red welt is the size of a small arrowhead and itched really bad last night/ had a red welt pop up in that area; he can still feel a raised place like a welt under the skin and it is like a small bruise under the skin; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: FN6207), via an unspecified route of administration, administered in Arm Left on 11Mar2021 15:30 (Age at vaccination 69 years) as dose 1, single for covid-19 immunization. Medical history included ongoing rheumatoid arthritis. Patient stated that he was diagnosed with rheumatoid arthritis about 10 years ago and has been on Methotrexate for a long time and little overweight. No family Medical History relevant to adverse events. Concomitant medications included methotrexate (METHOTREXATE) taken for rheumatoid arthritis. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not visited to emergency room and physician office. Vaccine was not administered at military facility (Hospital staff). Additional vaccines were not administered on same date of the Pfizer Suspect. On 21Mar2021, Patient reported that a red, swollen knot appeared at the injection site last night. This morning the swelling has went down, the knot can be felt under the skin and is in the shape of an "arrow head". He states you can only see a red whelp now. stated this morning the red welt is the size of a small arrowhead and itched really bad last night but does not itch this morning. Patient stated that the red welt is just like a little arrowhead and is like a little heart and it is kind of weird. He wants to know if this reported event was a common occurrence after receiving the Pfizer COVID Vaccine. He states the red welt was improved and was not near as swollen as it was and it had swelled up to a big knot and he could visibly see the knot but he cannot see the knot now. Patient stated his appointment for the 2nd dose of the Pfizer COVID19 Vaccine was scheduled for 01Apr2021. Patient did not received treatment for events. No lab test was performed. The clinical outcome of event red, swollen knot appeared at the injection site last night was recovering; the red welt is the size of a small arrowhead and itched really bad last night/ had a red welt pop up in that area was recovered on 22Mar2021 and he can still feel a raised place like a welt under the skin and it is like a small bruise under the skin unknown.  No follow-up attempts are possible. No further information is expected.
The same day she broke out in rash with headaches and dizzy spells. A couple of months later she started having seizures, severe headaches, stomach pains, anaphylaxis and several other problems.
Report describes fever in a 24 year old male who received an injection of hep A vaccine. Medical history, concurrent conditions, and concurrent medications were not specified. The vaccinee had no adverse experiences following receipt of prior immunizations. On 04/10/2001, the vaccinee received his first injection of Havrix and his first injection of rabies vaccine. The rabies vaccine was administered for pre-exposure prophylaxis. On 04/13/2001, three days post-immunization, the vaccinee experienced a fever of 104 degrees F., nausea, and vomiting. The events resolved in six to eight hours. The vaccinee subsequently received a second injection of Imovax without adverse event.
Patient vaccinated x3 (Pfizer: 4/21/21, 5/12/21, 2/19/22) Patient found to be COVID positive on 5/8/22 during hospitalization
Swollen area with hard lump at area of injection. Noticed it the morning after the shot.
was exposed to temperatures out of labelled; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: FL8094, Expiration Date: 25Apr2022) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown", described as "was exposed to temperatures out of labelled".  Additional information: The product was subjected to storage conditions of 2 degree C to 8 degree C for a total of 80 days. Stability data does not support the use of this product following this deviation. Pfizer could not authorize storage of any product outside the approved labelled conditions. Additionally, Pfizer could not make any disposition decisions for product outside Pfizer's control. Any decision to release or dispose of the impacted products based on provided information or other information was the responsibility of Clinic.
Chills; Mild ar m soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild ar m soreness) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 020L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for Hyperlipidemia, LISINOPRIL for Hypertension, LEVOTHYROXINE for Parathyroid tumor malignant.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Mild ar m soreness). On 17-Feb-2021, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 18-Feb-2021, CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Mild ar m soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-020736 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up recieved on  28-APR-2021 included added patient birth date demographics, stop date of event chills secondary reporter contact information
Mother brought pt into clinic 3 days post immunization. Right upper deltoid area with palpable induration, redness and warmth. 7x5cm redness right arm 20cm circumference. Advised Motrin/Tylenol for pain, cold compresses. Return if sx's worsen.
Heart palpitations--approximately 2-3 times per day for a week or two. The symptoms are not as frequent now, just once in a while. I have not seen a doctor, just trying to rest/avoid strenuous exercise, eat healthy foods, and avoid caffeine.
seeing smoke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; latanoprost (LATANOPROST), (Batch/Lot number: unknown); ibuprofen (IBUPROFEN), (Batch/Lot number: unknown); brimonidine tartrate, brinzolamide (SIMBRINZA), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISION BLURRED (non-serious), outcome "unknown", described as "seeing smoke". The action taken for latanoprost, ibuprofen and brimonidine tartrate, brinzolamide was unknown.  Additional information: Caller stated that her eye doctor had her taking Latanoprost ophthalmic solution, which was from Pfizer and she was taking it with her Simbrinza. On the first night she took nothing extra and was fine. She had taken Ibuprofen at 2am, woke up this morning and it was like smoke was in the house. Clarified that she looked at the lights in the ceiling and guessed that she had a reaction. Wanted to know if she could take Ibuprofen with Latanoprost ophthalmic solution. Was tipped off about something else she was on and told that what information one gets from the manufacturer was not conclusive. Wanted to find out why she was seeing smoke and to know if was this permanent or if would reverse itself. As she was looking it says nothing about don't take Ibuprofen. Wished that she would have known that Latanoprost ophthalmic solution was from Pfizer. She never had any problems until took she took the Covid shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
throat tightness; sore throat; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Dec2020 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient reported that 4 hours later she started to have throat tightness that lasted through the night. Caller reported during the call that the tightness was no longer present but she now had a sore throat. Outcome of event throat tightness was recovered in Dec2020, and outcome of event sore throat was unknown.  Information on the lot/batch number has been requested.
Child woke up with a fever of 103F. Child was shaking and would not respond to parents. Skin was very pale. Child recovered within minutes. Febrile seizures returned about 3-4 times in the course of the morning. The fever remained high. The febrile seizures did not return in the evening, but the fever remained for about 3 days, staying over 100F.
Fever 1.07 Uncontrollable Chills Exhausted  Diarrhea
Patient received the first dose intramuscularly instead of subcutaneously. Wrong route of administration.
Patient was under the age of 18 and received JJ by accident. Both patient and provider were informed.
At 1348 client approached EMT to ask if neck tension was normal. EMT did first set of vitals and assessment. Vitals at 1348: blood pressure 148/100, pulse 79, oxygen sat 99%. Per client "slight dizziness" and headache. EMT gave client water. PHN arrived at 1353. Client sitting upright in chair, alert and oriented x4. Medical history of TMJ and headaches, no daily medications and no known allergies. At 1355 client states "slight pressure on chest". Client denied shortness of breath, blurry vision, chest pain. Per client headache 1/10 pain, chest pressure also 1-2/10. PHN offered client paramedics for further assessment and client declined. Vitals at 1400: blood pressure 150/102, pulse 84, oxygen sat 98%. Client reported dizziness and headache improving. Chest pressure 1/10. Client alert and oriented x4. Vitals at 1407: blood pressure 146/92, pulse 77, oxygen sat 98%. Per client headache, dizziness and chest pressure improving. Client described chest pressure as "anything mild". Vitals at 1414: blood pressure 150/98, pulse 74, oxygen sat 98%. Client reported to PHN feeling stressed due to work. Per client headaches are common for him. At 1417 client stated chest pressure "back to normal". Client denied chest pain, blurry vision, shortness of breath, or dizziness. PHN advised client to follow up with provider and gave ER precautions. Last vitals at 1424: blood pressure 142/99, pulse 72, oxygen sat 99%. PHN asked client if someone could drive him home. Client stated he "felt fine to drive". Client left facility with steady gait at 1428.
Symptoms:  Weak, tired, Vertigo/loss of balance for entire day (Day after receiving Moderna booster shot).  Retired, so spent day on couch, but didn't want to move or get up.  Lost bladder control.  Spells of dizziness and headache.  Didn't seek medical attention.  Slept better second night and returned to normal activities the following day.  Approximately 18 hours of not being able to function normally and having combination of the above symptoms.
I have a stroke in July; This is a spontaneous report from a contactable consumer (patient). A 78-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration at the age of 78-year-old on 25Mar2021 (Lot Number: EN6207) as single dose for COVID-19 immunisation. Medical history included High blood pressure (on High blood pressure medicine), blood disorder (on blood thinners), immunisation. Concomitant medications included influenza vaccine taken for immunisation, start and stop date were not reported; acetylsalicylic acid (ASPIRIN) taken for an unspecified indication, start and stop date were not reported; on blood thinners medication (unspcified), on High blood pressure medicine (unspcified). The patient previously took first dose bnt162b2 (The LOT# for first is EL9266) at the age of 78-year-old on 26Feb2021 for COVID-19 immunisation and experienced arm is sore. The patient experienced 'I have a stroke in july' in Jul2021. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
I had to present to Urgent Care on 11/16/18 (per Pharmacist) for local reaction. Redness, swelling, soreness, large baseball sized lump. Took TYLENOL for pain and am now on Prednisone for 5 days (20 mg tabs - 2 x day). $40 co-pay.
This is in follow-up to report(s) previously submitted on 5/14/2007.  Initial and follow-up information has been received from a Licensed Practical Nurse (L.P.N.) concerning an 18 year old female student with no pertinent medical history or drug reactions/allergies who on 17-APR-2007 at approximately 3:55 PM was vaccinated IM in left deltoid with a first dose of Gardasil (lot # 0378U not valid). Concomitant therapy included ZYRTEC. On 17-APR-2007 at approximately 4:00 the patient fainted in her chair soon after the administration of her first injection. She recovered quickly after she was placed on the floor and her legs were elevated. This is one of three reports from the same source.  Additional information has been requested.
the patient was administered improperly stored VARIVAX; This spontaneous report was received from a physician, referring to a 3-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 13-JUL-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, subcutaneous (lot number S032355 which has been verified to be valid, expiration date reported and validated as 14-OCT-2021) (dosage, vaccination scheme, frequency, anatomical site of injection were not reported), as routine vaccination (prophylaxis), reconstituted with a properly stored sterile diluent. The administered dose of the vaccine was stored at a temperature of 6 degrees Fahrenheit (F) to 14 F (13.66 F), during a time frame of 12 hours (multiple excursion) and at a temperature of 15 F to 46 F (16.0 F) for 30 minutes, as recorded by a digital data logger. There was no previous temperature excursion.
Large local swelling; redness at injection site (measures 14 cm round). Recommended ibuprofen, BENADRYL and cool compress.
Shingles developed on front and back torso.  Initial Treatment: Medro Pak 4mcg 6 days, Acyclorir 400 mcg 7 days,Tramadol 50 50 mg 10 days.  Second Treatment upon second visit ; Gabapentin 300 mg  daily for 30 days with 2 refills.
Initial information received on 17-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old female patient who experienced patient had been mistakenly given QUADRACEL and patient had been mistakenly given QUADRACEL, while she received vaccine QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Aug-2018, the patient received a  dose of suspect QUADRACEL lot C5325BA via intramuscular route in the right thigh. It was a case of actual medication error due to Inappropriate age at vaccine administration and Wrong vaccine administered. It was unknown whether patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Petechiae and fatigue led to CBC subsequent evaluation revealed aplastic anemia. 6/28, 7/1, and 7/5 vesicle (blister), swelling vaccine site. 7/2 and 7/3 muscle pain, itching on body. 7/11 scab vaccine site. 7/1 and 7/5 redness. 7/16 scab fell off. 7/1 itching vaccine site.  Per 60 ay follow up pt has not recovered. On treatment with anti ? globulin and cyclospaule with improvement in aplastic anemia. An annual follow up report received 01/13/2004 adds: Not recovered. We do not believe that the aplastic anemia is related to vaccine, but cannot exclude. Aplastic anemia has not resolved.
Headache, Myalgia & Fever Narrative:  fever myalgia h/a for 2d after #2 dose  covid test neg on 2/3/21
petechiae;platelets of 6,000;no improvement w/IVIG now receiving 10 steroids;
Throat and neck begun tightening; Heart rate fluctuating up and down for three consecutive times; Fast heart beat; Dizzy; blurry vision; Entire left arm was red; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine, and who experienced feeling throat and neck begun tightening,  heart rate fluctuated up and down for three consecutive times, dizzy, blurry vision, entire left arm was red and fast heartbeat.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included sertraline and levothyroxine sodium.  On 28 Dec 2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 027J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 28 Dec 2020, patient experienced feeling throat and neck begun tightening, dizzy, blurry vision, entire left arm was red, fast heartbeat and heart rate (135 beats/min) fluctuated up and down for three consecutive times. Treatment included epinephrine injection. Patient was sent to the emergency room for three hours where she was given intravenous fluids.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the events, feeling dizzy, blurry vision, entire left arm was red, fast heartbeat and heart rate fluctuated up and down for three consecutive times, was considered recovered/resolved on 28 Dec 2020. The outcome of the event throat and neck begun tightening was not reported.; Reporter's Comments: This spontaneous report refers to a case of a female patient who experienced events of feeling throat and neck begun tightening, dizzy, blurry vision, entire left arm was red, fast heartbeat and heart rate (135 beats per minute) fluctuated up and down.  The events developed on the same day after the administration of the mRNA-1273 vaccine (Lot# 025J20A, expiration date-unknown. Treatment administered include Epi-Pen, IV fluid, normal saline. Outcome is resolving.  Based on the information provided which includes a temporal association, a causal association cannot be excluded.