chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme lower back pain. Started approx 2 hours after injection. Haven't decided to go to Dr. about it. Not sure if from vaccine or coincidental. However I have no history of back issues/pain.; This is a spontaneous report from a contactable other healthcare professional (patient) who reported for herself.   A 46-year-old non-pregnant (at the time of vaccination) female patient received first dose ofBNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6202), via an unspecified route of administration, administered in left arm on 23Feb2021 at 13:45 (46-year-old at the time of vaccination) as single dose for covid-19 immunization. Patient medical history was none. Concomitant medications included sertraline and chlorphenamine maleate (CHLORPHENIRAMINE C). Patient had no known allergies. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient had no Covid prior vaccination; Patient was not tested for Covid post vaccination. On 23Feb2021 at 15:45, the patient experienced extreme lower back pain that started approx. 2 hours after injection, and she has not decided to go to doctor about it as she was not sure if from vaccine or coincidental. However, she had no history of back issues/pain. Patient did not receive any treatment for event. The Outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Injection site was sore; Bruising at injection site; Injection site was also swollen; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration in the left arm on 28Mar2021 at 13:15 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. The patients medical history included allergies to penicillin. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 07Mar2021 at 13:15 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021, the patient experienced bruising at injection site, injection site was swollen and injection site was sore. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events bruising at injection site, injection site was swollen and injection site was sore were recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Headache; body aches; chills; low grade fever 100 degrees Fahrenheit; Soreness to the right arm where vaccine was administered.; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on right arm on 18Dec2020 03:00 PM, single dose for COVID-19 immunization at 60-year-old. Medical history included: COVID-19 diagnosed prior to vaccination. Concomitant medication was not reported. No other vaccine received within 4 weeks prior to the COVID vaccine. On 19Dec2020 12:00 PM, the patient had headache, body aches, chills and low-grade fever 100 degrees Fahrenheit. At the same time (19Dec2020 12:00 PM), the patient had soreness to the right arm where vaccine was administered. No treatment received for above adverse events. Lab data included: COVID-19 (positive) diagnosed prior to vaccination; 100 degrees Fahrenheit low-grade fever on 19Dec2020. Since the vaccination, the patient had not been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolved in Dec2020. It was reported as non-serious.  Information on the lot/batch number has been requested.
See other sheet. The next day after receiving my flu shot, I experienced hyperventilation and had to breath into a small brown paper bag. I also had a fever of 102-103 F with cold chills. I had nausea for 1 wk along with diarrhea. I had severe aching and pain in my muscles and stiffness in my joints. I had severe back pain esp in flank areas. I was told to call the doctor until the 3rd day after receiving the flu shot. I experiencing severe dizziness - my equilibrium was off and my gait was very unsteady - so much that I fell down 2 times I was pale, lethargic & depressed. I felt confused & disoriented. I developed severe sinus infections and fever blisters all over my upper & lower lips. My neck was very stiff and I had severe headaches, when I was finally able to go to the doctor, I was put on antibiotics, acyclovir and PHENERGAN. My flu test was negative. I was more sick than if I had the flu itself. I had no URI or congestion. I was told that I had a rare and severe reaction to the flu vaccine. I will never get another one. This was as sick as I have ever been. Thank you for the vaccine adverse effect form. It has been 1 wk now after receiving the vaccine, and I still don't feel well.
Breakthrough case admission after4 vaccines Moderna 2/28/21 lot# 025A21A;  Moderna 3/24/21 lot# 001B21A;  Moderna 11/17/21 Lot# 039F21A;  Moderna 4/21/22 lot# 002M21A;
freezing cold; nausea; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE for covid-19 immunization .The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced freezing cold and nausea. The outcome of the events was unknown.  Information about batch/lot number has been requested. Follow-up attempts are completed. No further information is expected.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered 1 in total on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications were not reported.  The patient commented that she recently experienced a breakthrough case of COVID (dates not specified) (coded to suspected covid-19 infection and suspected clinical vaccination failure). As per this report, the patient was recommended to receive the booster shot of vaccine in eight months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report associated with Product Quality compliant and PQC number has been requested.; Sender's Comments: V0: 20210851625-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient's shoulder joints began hurting after vaccine. It kept getting more and more severe, up to the point where he couldn't raise his arms. He also had some pain in thigh muscles but not as severe. Pain got so severe he went to ER - who did labs and told to see PCP. PCP gave naproxen for pain, which helped some. 3 days later - he went back to ER and he was given a muscle relaxer and IV morphine. He returned  back to PCP  and was given steroids and 2-3 days later had complete relief but still being treated on steroids.
Treatment:  Observation LN responded immediately, PT transferred to cot, walking without difficulty. PT was affable, responding appropriately to questions. PT reported itching to face, right and left arm, and lower back. No evidence of hives, swelling of face/tongue noted. No respiratory distress noted. VS at 900 were BP 124/82, HR 82, RR 18, SPO2 96% RA. EpiPens were made ready, but PT declined EPI treatment or calling 911. PT accepted 50mg Benadryl PO at 0901. PT reported that treatment was effective in reducing itchiness, especially to left arm, 15 minutes after Benadryl administration. VS at 0910: BP 136/80, HR 83, RR 18, SPO2 98% RA. 0920 VS: 134/78, HR 74, SPO2 98% RA. VS at 0930: BP 124/82, HR 76, SPO2 97% RA. PT self-administered 10mg Zyrtec at 0922 from his personal supply. PT remained stable throughout episode of care, with no changes to mentation, vital signs, breathing. PT educated on s/s anaphylaxis, when to seek medical help. PT verbalized understanding of education, reports he plans to take a repeat dose of 50mg Benadryl in 4-6 hours, if needed. PT reports that he is a firefighter and that he would not be home alone.    Outcome:  PT reported that he felt safe and ready to return home. PT returned to post-observation area to wait through partner?s observation period, will exit with partner.    Witnesses:  RN, RN, ARNP, RN.
Headache 10:30 a.m./chills 11:00 a.m./ temperature taken 11:10 a.m. 102.3/general fatigue  Fever broke 6:00 p.m. same day, chills went away.  Woke up on April 4, no symptoms
started experiencing all the symptoms last week Wednesday and tested positive; started experiencing all the symptoms last week Wednesday and tested positive; This is a spontaneous report from a contactable consumer (patient). This (Age: 55; Unit: unknown) female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIOTECH-COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry was not reported), via an unspecified route of administration on 26Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient started experiencing all the symptoms last week Wednesday and tested positive yesterday (11Apr2021) or today (12Apr2021) with lab test sars-cov-2 test. Second dose was scheduled for this Friday and she would like to know whether she could get the 2nd dose of the covid vaccine as she has tested positive for covid or whether she would need to start the vaccination series again if she was unable to get the 2nd dose of the covid vaccine as scheduled. And she was suggesting that they need to put something happier on hold music because she already felt like she was dying. The outcome of started experiencing all the symptoms last week Wednesday and tested positive was unknown.  Information about the Lot/batch number has been requested.
Information has been received from a physician concerning a 14 year old female patient with unspecified allergies and no pertinent medical history who "one year ago" in January 2010, was vaccinated with a 0.5 ml first dose of GARDASIL (Lot# not reported), IM, and a dose of AFLURIA (manufacturer unknown). The patient developed fever after receiving her first dose of GARDASIL and AFLURIA (manufacturer unknown). On 18-JAN-2011 the patient was vaccinated with a second 0.5ml dose of GARDASIL (Lot #1664Z), IM, and a dose of FLUZONE. Physician stated that on approximately 19-JAN-2011 the patient's eyes swelled shut, her chest got tight, and her throat felt tight after administration of GARDASIL and FLUZONE during the same visit. The patient was treated with BENADRYL at home. There were no laboratories diagnostic studies performed. The physician examined the patient at the time of the report on 19-JAN-2011 and the patient was feeling better. Follow-up information has been received from the physician who reported that the female patient was vaccinated with 0.5ml first dose of GARDASIL (Lot# not reported), IM , and a dose of AFLURIA (manufacturer unknown). "One year ago" in January 2010, unknown time and experienced fever of 102 degrees F. On 17-JAN-2011 (previously reported as 18-JAN-2011) the patient was vaccinated with a second 0.5ml dose of GARDASIL (Lot# 666163/0664Z, Exp Date 12-SEP-2012) (Lot# previously reported as 1664Z) and a 0.5 ml dose of FLUZONE, IM. Unknown time. The physician stated that on 17-JAN-2011 experienced shortness of breath that lasted 2 days and after the second dose of GARDASIL was administered on approximately 17-JAN-2011 her lips swelled and got 99.6 degrees F of temperature. On 19-JAN-2011 the patient had recovered from these symptoms. No further information is available.
Received Meningococcal vaccine on 8/02/16 and the injection site is larger than a saucer, smaller than a dinner plate. Red, Swollen, Warm to the touch and painful, worse on 8/4/16. Advised of evaluation.
Patient sent to express care via w/c after receiving 1st dose of Covid-19 vaccine due to complaints of dizziness and elevated BP readings.  Staff nurse  reports patients BP was elevated and c/o dizziness  voiced. Dr and NP notified of patient's vital and status. Blood pressure readings were 200/100. Patient was taken to the ED for further care.  BP monitored every 15 minutes x 1 hour and EKG performed.  Patient sent to ER via w/c escorted per nurse due to elevated BP.
A few hours after the shot my left arm was VERY sore.  It felt as if someone had hit me with a metal rod. I started to feel chills and back pain around 7 pm.  Throughout the night my arm was throbbing and I had a hard time sleeping. I woke up around 12 am to use the restroom. My body felt VERY heavy and weak. I woke up today (1 day after the shot) and felt better.  However, my arm still has severe pain and I experiencing fatigue. I also feel like the back pain goes in and out.
Neutropenic fever. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Breakthrough case admission after 4 vaccines Moderna 1/29/21 lot# 004M20A;  Moderna 5/26/21 lot# 005C21A;  MOderna 11/5/21 lot# 076C21A;  Moderna 4/21/22 lot# 056M21A
pt recv 1dose of varivax 4/8/98 & 4/19 pt devel chickenpox all over the body. rpt rash lasted 7 days. treated w/benadryl & caladryl
pt recv vax; small red area, swelling; 5jun95 intense itching; dph given; 12jun95 resolved;
After about 14 hours receiving my second dose, had severe chills with shaking/shivering for about a half-hour. Then a slight fever for about 6 hours. Then body aches- muscles and joints for 6 hours.  Then it went away with mild fatigue for a couple days.
Due to extensive history of allergies and concerns she was pre-medicated 30 minutes prior to vaccination with 25 mg of Benadryl. At 1209 she started getting anxious and having tingling on her tongue. She progressed to nausea, throat tightness, shaking and then chest pain. EMS was called to transport to the ED
Chills,severe headache and nausea starting 8 hours after injection.  Loss of appetite and fatigue, weakness the entire next day.  On third day after injection severe headaches started at night (5/29) and continued for 6 days.  Had to get Tylenol 3 (codeine) as normal OTC meds couldn't touch the headaches.
Patient had 2 seizures about 5 minutes after receiving her first Covid vaccine.  Spouse was with her and did not think seizure was due to vaccine, but that she has a history of seizures if over anxious or becoming overheated.  They did not want me to call 911 and seizures resolved.
injection site is swollen, red, and warm to the touch; the lymph node on the same side where I had the injection is swollen; hands and arm were tingling; hands and arms were numb; injection site is swollen, red, and warm to the touch; injection site is swollen; hard knot in my arm that has been here for over a week now; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (injection site is swollen, red, and warm to the touch), LYMPHADENOPATHY (the lymph node on the same side where I had the injection is swollen), PARAESTHESIA (hands and arm were tingling), HYPOAESTHESIA (hands and arms were numb) and VACCINATION SITE ERYTHEMA (injection site is swollen, red, and warm to the touch) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site is swollen, red, and warm to the touch), LYMPHADENOPATHY (the lymph node on the same side where I had the injection is swollen), PARAESTHESIA (hands and arm were tingling), HYPOAESTHESIA (hands and arms were numb), VACCINATION SITE ERYTHEMA (injection site is swollen, red, and warm to the touch), VACCINATION SITE SWELLING (injection site is swollen) and INJECTION SITE INDURATION (hard knot in my arm that has been here for over a week now). At the time of the report, VACCINATION SITE WARMTH (injection site is swollen, red, and warm to the touch), LYMPHADENOPATHY (the lymph node on the same side where I had the injection is swollen), PARAESTHESIA (hands and arm were tingling), HYPOAESTHESIA (hands and arms were numb), VACCINATION SITE ERYTHEMA (injection site is swollen, red, and warm to the touch), VACCINATION SITE SWELLING (injection site is swollen) and INJECTION SITE INDURATION (hard knot in my arm that has been here for over a week now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: Additional events were provided.
Presented to ED with generalized weakness, SOB.  Patient was diagnosed with pneumonia due to COVID-19 virus, tx with oxygen, antibiotics, remdesivir, steroids; weaned from O2 to RA but remained debilitated & weak; dc'd to rehab.
wanted to sleep a lot; tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing), notes: Comments: Diabetes; "Pulmonary hypertension" (ongoing), notes: Comments: Pulmonary hypertension,she was on high dose steroid for her Pulmonary Hypertension; "Arthritis" (ongoing), notes: Comments: Arthritis; "Overweight" (ongoing), notes: Comments: Overweight A little Overweight; "Hemolytic anemia" (ongoing), notes: Comments: Hemolytic anemia; "Migraine" (ongoing), notes: Comments: Migraine; "Pacemaker" (ongoing), notes: Comments: Pacemaker; "Oxygen 24 Hours" (ongoing), notes: Comments: Oxygen 24 Hours; "Massive Blood Clots" (ongoing), notes: Comments: Massive Blood Clots; "Compromised Immune System" (ongoing), notes: Comments: Compromised Immune System; "Heart and Lung Disease" (ongoing), notes: Comments: Heart and Lung Disease; "Heart and Lung Disease" (ongoing), notes: Comments: Heart and Lung Disease; "Lupus" (ongoing), notes: Comments: Lupus. Concomitant medication(s) included: COUMADIN taken for thrombosis. Vaccination history included: BNT162b2 (First Dose: 03Mar2021 Given at (name-withheld)), administration date: 03Mar2021, when the patient was 60-year-old, for Covid-19 immunization, reaction(s): "it took her energy away", "her arm started hurting", "her legs got weak", "she almost couldn't get up on the bus". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tired"; SOMNOLENCE (non-serious) with onset 2021, outcome "unknown", described as "wanted to sleep a lot". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated she was trying to lose weight. She was on a high dose steroid for her pulmonary hypertension because it was really bad, and the high dose steroids caused her to gain weight. The reporter stated she tries to take care of herself. She was on coumadin because she has massive blood clots. Regarding investigations, the reporter stated they were always drawing PT/INR tests and running other tests such as CBC because her red blood cells were too big. She had hemolytic anemia. Stated she had macrocytic cells because they were so large. If her Hemoglobin and Hematocrit dropped, she had to go back to the cancer doctor again. Pfizer Covid 19 Shot Second One adverse event: reporter stated with the second one she was really tired, and she wanted to sleep a lot but with this one {sixth one) she feels weak and sick and when she saw her temperature went up, she thought as long as it went down, she didn't worry about it. Given on 25Mar2021. NDC, Lot, Expiration: Unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe, Symptomatic Low Flow Low Gradient Aortic Stenosis - Successful Transcatheter Aortic Valve Replacement. Post procedure the patient did very well. He was transferred to the 4N cardiac procedures unit and monitored closely overnight.  He worked with PT/OT and progressed quickly to baseline function.  Hospital admission within 6 weeks of receiving the COVID vaccine.
Facial numbness, blurred vision, dizziness, nausea, chills, headache, speech production affected
Two days post vax, 02/24, the pt noted that scalp and ears were itchy and then had redness and itching of belly button and chest. Rash noted on chest. On 02/27, pt states that she had pain under breasts like a vice was round her chest. The following day, this chest pain worsened. There is no swelling or redness on her right arm, only some soreness. On 02/29 she was urged by PHN to be evaluated as soon as possible by a physician. At the ER, the diagnostic impression was adverse reaction to the vax. She was told to take either Ibuprofen or Naproxen every 6 hours as needed and to avoid future Hepatitis B vaxs.
This spontaneous report as received from registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 10-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # M034780, expiration 15-APR-2019 (dose and route of administration were not reported) for prophylaxis. No adverse effect. Temperature:  -1 degrees Celsius (C) or colder (-1.1 C). Time Frame: 4 days 45 minutes. No previous temperature excursion. Digital Data logger report was involved. No further information was provided. This is one of two cases from the same reporter. Additional information has been requested.