chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a headache/pressure in her head/chronic headache; felt numbness in my left arm, & down to my fingers; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (felt numbness in my left arm, & down to my fingers) and HEADACHE (I had a headache/pressure in her head/chronic headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced HYPOAESTHESIA (felt numbness in my left arm, & down to my fingers). On 17-Jan-2021, the patient experienced HEADACHE (I had a headache/pressure in her head/chronic headache). At the time of the report, HYPOAESTHESIA (felt numbness in my left arm, & down to my fingers) outcome was unknown and HEADACHE (I had a headache/pressure in her head/chronic headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-235599 (Patient Link).
pt recvd vax 28JUN94 & that same day devel swelling, redness & soreness under the arm which lasted for approx 48hrs;pt fully recovered;
Baby got very dry, red, rash on each thigh that got the shots - recurred after dose 2 & 3 also.
discharge summary "Patient initially admitted to ICU for bilateral SFA occlusion shown on CTA aorta with runoff, pt underwent catheter directed thrombolysis with improvement however complicated by hemorrhage to previous L3-L4 laminectomy site s/p hematoma evacuation 4/19 requiring pressor support as well as 2 units pRBC transfusion. Patient was successfully resuscitated in the ICU and no further bleeding was noted after being placed back on systemic anticoagulation. Patient was started on ASA at a later date per neurosurgery and is to restart Plavix on 5/3. Pt hospital stay was complicated by cellulitis of foot, which improved after the initiation of abx "
This spontaneous report as received from a nurse practitioner refers to her currently 16 years old son. The patient's historical conditions included increased blood pressure when the patient received ketamine as an anesthetic for unspecified procedure (in approximately 2000, when the patient was 2 years old). On an unknown date (reported as when he was in kindergarten), the patient experienced meningitis after receiving a dose of DTAP vaccine (manufacturer unknown) and IPV (Described in MARRS # 1403USA003195). In 2008 the patient experienced very high fever, generalized lymphadenopathy and neurologic symptoms which included repetitive motions and sensory issues where he could not tolerate any normal sound and became very sensitive to touch after vaccination with VARIVAX (Merck) (Described in MARRS # 1403USA007224). In 2008 the patient's sister experienced generalized lymphadenopathy, platelet level dropped, abnormal platelet function, dropped level of platelets, petechia, nose bleeds, bruising, profuse itching and very large urticaria on her thigh after vaccination with VARIVAX (Merck) (Described in MARRS # 1403USA007226). The reporter stated that both her son and daughter (Described in MARRS # 1403USA007227) received a dose of GARDASIL and both experienced severe reactions. On an unknown date the patient was vaccinated with GARDASIL (dose, strength, route and site of administration not reported). Other suspect therapies included influenza virus vaccine (unspecified, manufactured by Sanofi Pasteur) (dose, strength, route and site of administration not reported) received on the same day. The reporter stated that the patient did not experienced fever but his neurologic symptoms he experienced with VARIVAX (Merck), such as sensory sensitivity and motor activity issue returned within first 12 hours of receiving GARDASIL. About a month after receiving GARDASIL, the patient experienced multi-joint swelling and found to have high (Antistreptolysin O) ASO titer for strep infection. The reporter stated that neurological symptoms for her son after receiving GARDASIL persisted for about 2 months then the patient became somewhat better after 6 months. The outcome of the events was not reported. The relatedness between events and suspect therapy was not reported. The reporter stated her children were very sensitive to vaccines and she was closely working with allergist and immunologist to find the cause for these reactions and she also mentioned that level of alum present in GARDASIL might be linked to these symptoms. This is one of three same patient cases from the same source (MARRS # 1403USA007224, 1403USA003195). This is one of several cases from the same source (MARRS 1403USA003195, 1403USA007224, 1403USA007226, 1403USA007227, 1403USA007228). Additional information is not expected.
Relaxing on couch-normal day.  Suddenly felt very sweaty-hair wet - decided to wash face - went into bathroom- Quick reaction - Instant  diarrhea and vomiting in bucket.  Very scary - asked husband for more toilet paper.  After cleaning up, I was extremely COLD.  Put on extra clothes sweatshirt - got 3 blankets, by now it is 1:30 A.M.   Slept in recliner.  Next morning - felt weak, unsteady - afraid to eat anything but did drink lots of water.  Today is Sunday April 11th, still very cautious about eating and still taking it easy.  Seem to have a  little discomfort in sternum area (thinking this could be my "years ago diagnosed hiatal hernia ??
I received the first vaccine Friday March 19, 2021, I woke up Sunday, March 21, 2021 with severe vertigo. It lasted over 3 1/2 weeks. I saw a neurologist, was sent to vestibular physical therapy.  It was determined I was experiencing BPPV. The extremely disabling vertigo subsided but I still felt off.   I received the second vaccine Friday April 16, 2021. I was very tired and nauseated. I had occasional episodes of dizziness and nausea. On Monday April 19, 2021 I continued to deal with dizziness and nausea but it was intermittent and not as severe as the first episode of vertigo. I have experienced dizziness and nausea daily since. It comes and goes. I returned to the neurologist and the vestibular physical therapist, this is not BPPV. My eyes are displaying a down-beat movement. Nothing is relieving the dizziness and nausea at this time. A CT scan has been ordered.
This spontaneous report was received from registered nurse concerning her 15 month old grandson. Reporter stated that she learned from her daughter-in-law and son that on an unknown date, in the last few days, the patient was vaccinated with a dose of M-M-R II (lot number, expiry date, dose and route unspecified) at well baby check up. No concomitant medications were reported. On an unknown date (reported as later), the patient was diagnosed with an ear infection for which the doctor prescribed BACTRIM (manufacturer unknown). The reporter did not have the information regarding pediatrician. The patient did not seek any medical attention. No lab tests were performed. The patient was running around and fine at the time of reporting. The relatedness for ear infection was unknown for M-M-R II. Additional information is not expected.
hives that started about 4 hours later, pt reports itching.  No images available and consult with patient was via Telephone consultation
There was no adverse event, This was an administration error as the patient was accidentally given an adult Pfizer dose.
Fever; fatigue; joint pain; nausea; Severe diarrhea; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0179), dose 2 via an unspecified route of administration, administered in right arm on 11Jun2021 at 17:45 (at the age of 36-year-old) as single for COVID-19 immunisation at pharmacy or drug store. The patient medical history included chronic pain, insomnia and breast cancer. The patient did not had known allergies. Concomitant medications received in two weeks included eszopiclone, ibuprofen, pseudoephedrine hydrochloride (MOTRIN COLD & FLU); oxycodone and pregabalin. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0176), dose 1, administered in right arm on 21May2021 at 17:30 (at the age of 36-year-old) as single for COVID-19 immunisation. No past drug events were reported. The patient did not receive any other vaccines in 4 weeks and on same date of vaccine. The patient was not diagnose with COVID prior to vaccination and was not tested for COVID post vaccination. On 12Jun2021 at 14:00, the patient experienced fever, fatigue, joint pain, nausea and severe diarrhoea. No treatment was received for the events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Headache, NauseaVomiting, Extreme fatigue Narrative:  slight swelling/discomfort at injection site for 3 days Day 1 runny nose, congestion day 2 extreme fatigue-could not get out of bed Day 3-Headache 6/10 pain level and extreme fatigue and nausea Day4-Extreme fatigue.
arm pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) and HEADACHE (Headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, PAIN IN EXTREMITY (arm pain) had resolved and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided. Treatment medication not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-067245 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067245:crosslinked with dose 2
Approx 20 hours after immunization pt c/o itching, rash over body, swelling mother took to ER. Pt given Roceneic Epinephrine updraft, Prelone, Tagamet. Much improvement with treatment.
Dizziness, Headache, Myalgia, Arthralgia, Fever, Numbness in injection arm Narrative:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 1:47 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 1:47 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 70.35.  Concomitant products were not provided.  On 27-Oct-2021, Excursion time was 09 AM and 10 AM, temperature was 29 and 32 respectively, total doses given for the day was 116, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-Sep-2021 and 05-Oct-2021, vial was moved to clinic on 27-Oct-2021. 6 vials were sent to clinic. Vaccine BUD date was 27-Oct-2021 and 04-Nov-2021.  On 27-Oct-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM: 43, 2 PM: 46, 3 PM: 46, 4 PM: 46 and 5 PM: 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
This spontaneous report was received from a pharmacist refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with a dose of improperly stored M-M-R II, (lot number, expiry date and route was not reported). No adverse effects were reported. Additional information is not expected.
Swollen, red, warm upper left arm where 2 immunizations given less than 24 hours ago. Told to apply ice to area, give 1 tsp Motrin TID, return if worse and avoid IPV and pertussis in future (should get DT only).
approx 5mins p/vax became pale w/brief LOC & momentary rigidity of arms; in less than 1 min p/onset of s/s, skin became pink & dry w/subsequent crying; BP 108/62;
Could not raise arm without pain. After one week and since can raise arm but still have pain.  Went to doctor. Is now 7 weeks and 3 days  since shot. Second shot was given in left arm.
Increased pain 2 hours after recieiving vaccine, pt developed a large localized reaction in her arm including a large amount of swelling that went from the injection site radiating distal and proximal, increased pain, redness, hot when touched.
Went to pharmacy and received the shingrix. next morning noticed had redness and swollen at injection site. Day after day started seeing hives appear. Hives appearing on both arms and my back. Started putting hydro cortisone cream on area. Just called my Dr today and i'm waiting on a call back.
Medication Error- Gave a 3rd dose.  2nd dose  was given 1-27-2021.  First dose was given 12/30/2020.
diarrhea; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 immunisation, lot number: EL9261. Medical history included blood pressure high, thyroid gland disorder and thyroid surgery (patient had her thyroid surgery, they took a part out). Concomitant medications included rosuvastatin, losartan for blood pressure high and levothyroxine sodium (SYNTHROID) for thyroid disorder. It was reported that patient got the vaccine on 25Jan2021 and she was doing good, but on 27Jan2021 morning she got the diarrhea. Patient did not take anything for diarrhea. Due date for the next shot: 22Feb2021. Patient stated that she did not got to the doctor she went to Hospital (as reported). Patient had not recovered from the event.
MILD SWELLIG BILATERAL HANDS WITH INTERMITTENT PAIN IN THUMB & 1ST FINGER Narrative:
Burning/stinging at time of injection, It lasted for about 1/2hour 45 minuets. Red swelling, tenderness increased after 24 hours and continued to increase after 72 hours. After 78 hours red itching rash appearing  on chest, neck, back and torso.
Sore arm at the injection site; This is a spontaneous report received from a non-contactable consumer. A 33-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 22Mar2021, (at the age of 33-years-old) as a single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021, the patient experienced sore arm at the injection site. The adverse event had not resulted in doctor or other healthcare professional office/clinic visit/ emergency visit/ department or urgent care. No therapeutic measures were taken as a result of vaccination site pain. The clinical outcome of the event vaccination site pain was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
Evening of 1/21/2012, one week after vaccine,  noted new onset localized swelling just below injection site.  On 1/22/2012, area was significantly more swollen with redness warmth, itch, and induration of area approx. 10 cm in diameter.   Increased redness, swelling and itch on 1/23/2021.   Symptoms are slowly resolving but are not yet gone.   Throughout this time, I have experienced generalized fatigue and slight shortness of breath w/ occasional cough.
I had a rash on my arms, now have it on my legs and stomach; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 26Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced a rash on arms, now have it on my legs and stomach on 10Feb2021 (reported as past Wednesday) with outcome of unknown.    Follow-up attempts are completed. No further information is expected.
Pt. came in with left upper arm swollen and tender after receiving vaccination two days prior. Augmentin 12 days 1 1/4 tsp BID and Motrin 1 tsp every 4-6 hours. Parent advised to take pt. to ER with worsening of symptoms.
Information has been received from an office manager via a field representative referring to 29 year old female patient. The patient's pre-existing physician-diagnosed allergies, birth defects, medical conditions and illness at time of vaccination were reported as none. On 08-AUG-2018 the patient was vaccinated with her first dose of PNEUMOVAX 23 (lot # R002084, expiration date 26-OCT-2019; route, strength and dose were not reported) at right deltoid for prophylaxis. About 12 hours after vaccine was administered (on 08-AUG-2018), the patient started with severe arm pain. About 30 hours later (approximately on 09-AUG-2018), the patient experienced fever, chills, body aches and headache. The outcome of the events was reported as recovering. The causality between the events and PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1808USA005591.
38 yo massage therapist is reporting ADR to first covid vaccine (pfizer) on 4/6/21 -- onset 3 hours post vaccine he reports left arm pain and redness that progressed into swelling to left axillary and left clavicle. He reports using lymphatic drainage/massage/vitamins and ASA to resolve symptoms.  Symptoms lasted 8 days. Today he received his second pfizer vaccine. I advised we would call tomorrow to follow up and get the lot number of the vaccines.
injection site was swollen and it was painfull to lift the arm; injection site was swollen and it was painfull to lift the arm; high fever (104 F), high fever (100F), 99.3 F; muscle and joint pain; muscle and joint pain; chills; headache; This is a spontaneous report from a contactable consumer (Patient). A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0178, Expiry date was not reported), via an unspecified route of administration on 07Jun2021 11:00 (at the age of 34-years-old) in Arm Left as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient previously took analgin [metamizole sodium] and experienced allergy. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0177 and Expiry date was not reported), via an unspecified route of administration on 17May2021 12:00 (at the age of 34-years-old) in Arm Left as dose 1, single for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior vaccination and patient was not tested COVID-19 post vaccination. On 07Jun2021, the patient experienced adverse event 5 hours after receiving second dose, injection site was swollen and it was painful to lift the arm, 14 hours later she developed high fever (104 F), muscle and joint pain, chills and headache. The morning after still had high fever (100F), pain in muscles and joints. After taking one tablet of Paracetamol 500mg fever subsided to 99.3 F and the pain is almost gone. The Patient received treatment for the events Fever, pain in muscles and joints. The patient underwent lab tests and procedures which included body temperature: high fever (104 F) fahrenheit, body temperature: high fever (100F) fahrenheit, body temperature: 99.3 F fahrenheit. The outcome for the events was resolving.  Follow-up attempts are completed. No further information is expected.
This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received PREVNAR 13, via an unspecified route of administration in the upper arm on 07Nov2018 03:30 p.m., at a single dose  for protective from getting pneumonia, preventive shot. Medical history included 'mitral' valve that was just put in patient's heart four months from the time of the report (Jul2018) and allergy with penicillin. Concomitant medication included ongoing warfarin, oral for 'mitral' valve that was just put in patient's heart. On 08Nov2018 03:00 a.m., the patient reported having so much pain in her shoulder, elbow and arm that she cannot use it. The reported that she can use her fingers but cannot use her arm and having such a hard time with it. The patient reported being in the urgent care in the morning of the report. The outcome of the events was not recovered. Information on the batch number has been requested.