chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer-BioNTech COVID-19Vaccine EUA  Low-grade fever, chills, myalgia beginning around 8:00PM on the evening of vaccination. Symptoms resolved by morning.
Nausea and dizziness, pain in right side of neck, eye twitching from nerve in my eye.  Symptoms lasted for two days.
Initial and follow-up information has been received from a health care worker concerning a 5 month old white female with reflux, who on 16-NOV-2007 was vaccinated intramuscularly with a 0.5 ml first dose of COMVAX (Lot #657380/0377U). Concomitant suspect vaccination on the same day included ROTATEQ (MSD). Other concomitant vaccinations on the same day included, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine and (PREVNAR) (CRM197). Other concomitant medication included (PREVACID). On 23-NOV-2007, she was seen for episodes of irregular breathing. A chest X-ray showed infiltrates in one lung. On approximately, 28-NOV-2007, five days later a repeat chest x-ray showed infiltrates in the other lung. The infant was negative for respiratory syncytial virus (RSV). She was being monitored by pulse oximetry. At the time of the report the patient had not recovered. Follow-up indicated that it was determined that the patient probably did not have an adverse experience. It was reported that the patient made a full recovery on an unspecified date. Additional information is not expected.
APPROX. 24 HOURS AFTER VACCINATION PATIENT HAD A MASSIVE HEADACHE; FACE FELT LIKE IT WAS ON FIRE; NO APPETITE; FEVER 100.1; HR AS HIGH AS 120
Mom states first noted pt felt warm 1045PM; pt exp sz 11PM; Seen in ER 1158PM; mom denies pt had temp prior to 1045PM; mom states pt was adm to hosp w/pneumonia @ that time;
Intense, monthly, menstrual cramping and bloating; Intense, monthly, menstrual cramping and bloating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 (Lot number: EW0182) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0164, Location of injection: Arm Left), administration date: 16Apr2021, when the patient was 28 years old, for COVID-19 immunization. The following information was reported: DYSMENORRHOEA (non-serious), ABDOMINAL DISTENSION (non-serious) all with onset 26Aug2021, outcome "not recovered" and all described as "Intense, monthly, menstrual cramping and bloating". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysmenorrhoea, abdominal distension. Additional Information: Prior vaccinations within 4 weeks and other medications within 2 weeks were reported as none. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19. No follow-up attempts are possible. No further information is expected.
~8 hours after injection, and for the next 2 days: -Severe chills (fever of 103 degrees) -Severe shortness of breath -Racing heart (140 bpm) and High Blood Pressure -Body Aches -Blurry vision in both eyes -Nausea/vertigo/dizziness/headache  Most of the symptoms dissipated after a few days, but the shortness of breath and vision issues persisted for about a month.  After about a month's time, the vision issues went away, but the shortness of breath continues to this day.  I've been to the ER twice for the shortness of breath, and have been tested for C-19 SEVERAL times since the shot, all of which have been negative.  My primary care Doc prescribed me a rescue inhaler to help with the breathing difficulty, which only slightly helps.
pt recvd vax 8OCT92 & was vaxed w/2nd  dose 10DEC92 & following 2nd vax devel severe h/a, flu-like sx & myalgia; unable to attend work for 5 days; no further details were provided;
Sore throat, vomiting, lethargy, high fever, severe headache, racing heart.
After the 1st shot she developed a rash below her waistline. it covered all the way across the front of her lower body a d wrapped around her bottom. she also suffered from stiff fingers like joint pain. after a phone call to the doctor they didn?t think the rash was covid shot related.   she got the 2nd shot and 8 hours after injection she had joint pain behind her left knee. she she woke up the following morning she was unable to walk normal. that followed  with swollen ankles, joint pain in both legs, purpura all over the lower legs. bruise like. difficult walking. rash has continued to her upper thighs. feet still swollen after 8 days.
Periorbital puffiness on face, rash over rt abd & rash on rt leg.
Hot to the touch at the injection site after the second dose; Itching at the injection site after the second dose; Redness at the injection site after the second dose; Swelling at the injection site after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Hot to the touch at the injection site after the second dose), INJECTION SITE PRURITUS (Itching at the injection site after the second dose), INJECTION SITE ERYTHEMA (Redness at the injection site after the second dose) and INJECTION SITE SWELLING (Swelling at the injection site after the second dose) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) 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) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced INJECTION SITE WARMTH (Hot to the touch at the injection site after the second dose), INJECTION SITE PRURITUS (Itching at the injection site after the second dose), INJECTION SITE ERYTHEMA (Redness at the injection site after the second dose) and INJECTION SITE SWELLING (Swelling at the injection site after the second dose). At the time of the report, INJECTION SITE WARMTH (Hot to the touch at the injection site after the second dose) and INJECTION SITE SWELLING (Swelling at the injection site after the second dose) was resolving and INJECTION SITE PRURITUS (Itching at the injection site after the second dose) and INJECTION SITE ERYTHEMA (Redness at the injection site after the second dose) had not resolved.            No concomitant medications were reported. No treatment medication was reported.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.  Patient agreed to follow-up with Safety.   This case was linked to MOD-2021-032240 (Patient Link).
Patient walked in to the Health Department to receive what was supposed to be their first Johnson & Johnson vaccine. They filled out the necessary paperwork, and their immunization record was supposed to be checked for previous COVID-19 vaccination but was missed. The patient then received the 2nd Johnson & Johnson vaccine, and did not report they previously received the first dose. No adverse symptoms were reported.
This retrospective pregnancy case was reported in a literature article and described the occurrence of cleft palate in a neonate. The mother received Flu Seasonal QIV Dresden. The pregnancy resulted in a live neonate with a congenital anomaly. The neonate was diagnosed with cleft palate. Serious criteria included GSK medically significant, congenital anomaly and other: serious per reporter. Additional event(s) included maternal vaccine exposure and live birth. The outcome of cleft palate was unknown. The outcome(s) of the additional event(s) included maternal vaccine exposure (unknown) and live birth (unknown). The investigator considered that there was a reasonable possibility that the cleft palate may have been caused by Flu Seasonal QIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in this literature article and described the occurrence of cleft palate incomplete in a neonate of unspecified gender whose mother was vaccinated with unspecified seasonal inactivated influenza vaccine (manufacturer unknown) during pregnancy. The patient's mother was a part of the study that assessed the safety of seasonal inactivated influenza vaccines (IIV) and live attenuated influenza vaccines (LAIVs) in pregnant women and their infants whose reports were submitted to Vaccine Adverse Event Reporting System (VAERS) during 2010-2016. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient's mother received unspecified seasonal inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Subsequently, the patient was exposed to the vaccine in utero. On an unspecified date between 1 July 2010 and 6 May 2016, an unknown period after maternal vaccine exposure, the patient developed cleft palate incomplete. This case has been considered serious as per the authors. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between cleft palate incomplete and unspecified seasonal inactivated influenza vaccine. However the authors stated, "VAERS also generally cannot determine whether a vaccine caused an AE." The authors concluded that "During the study period 2010-2016, the average annual number of VAERS reports following IIV in pregnancy decreased compared with the 2009-2010 pandemic period but remained higher than prior to the pandemic. Similar to the 2009-2010 period, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010-2016. Maternal influenza vaccination benefits both the mother and the infant, protecting both from influenza disease. Given that the antigenic composition of these vaccines usually changes each season, the CDC and FDA will continue to monitor the safety of influenza vaccines in pregnant women." This is 1 of the 12 valid cases reported in the same literature article.
10/17, I had body aches specifically more intense in legs and groin. 10/18 I began to notice eye pressure/pain and was unable to wear contacts. 10/19 I was still experiencing eye pain and felt even more intense body aches and exhaustion. I spent half the day in bed. Prior to shot I haven't experienced any sickness or body problems (other than acid reflux) in over six months.
Fevers > 103 with TYLENOL.  Vomiting X 10.  Rash on face.
Arm and body aches and tiredness at night Fever, 101, shivering, headache all night in bed
Patient is a 81-year-old male with a past medical history of dementia and Parkinson's disease who presents to the ED coming from another facility with fever, chills, and witnessed aspiration event.  Patient is a resident of another facility who has dementia and Parkinson's disease with baseline mental status of alert and oriented to self only rarely speaks, uses wheelchair at baseline.  During time of exam patient is clearance and oriented to self only.  Attempted to contact patient's son but was unable to reach him.  Perceived patient history from ER physician and facility Nursing staff.  Over last few days patient has been having fevers with temperature of 100° Fahrenheit receiving Tylenol t.i.d..They also state patient has had chills.  Patient also had witnessed aspiration event today at lunch, afterwards had increased work of breathing.  There is no documented oxygen saturation, but night nurse had report of discolored lips.  ER physician reported son stated SpO2 in the 60% with this colored lives after aspiration event.  Patient was swabbed for COVID and flu over the weekend and negative.  Upon asking if facility had any COVID her flu going around they stated 1 patient at their facility was tested positive for flu today.  Will repeat COVID and flu swab today. PT REMAINS INPATIENT.
One day after 2nd Moderna vaccine infant had fever (expected side effect), then developed watery diarrhea that has continued for about 5-6 days. Also developed an erythematous maculopapular rash that lasted 2-3 days and was pruritic. Is fading now.
Both my husband and I got a flu shot and a tetanus shot in our left arms.  Both of us experienced severe aching, which we expected.  His went away after about 2-3 days.  Mine got slightly better, then got worse, until I could barely move my arm, and certainly not without pain.  My arm became red, itchy and so swollen that beyond where I could move my arm without pain, there was a lot of lost mobility where it was impossible to move my arm because of how swollen it was.  When I tried, even with pain, it would be like I had a physical barrier blocking my arm.  Also, it occasionally felt like a burning sensation in my arm, and it was certainly warm/hot to the touch.  As well as hurting to move, it also hurts to touch my arm. It has been a week now, and I am on antibiotics, but it is currently only slightly better.  I have difficulty sleeping, am unable to sleep on my left side, and I can barely move my left arm.  My husband actually has to help me with changing my clothing, it is so bad.
Had the vaccine eventually then I ended up getting the virus; I ended up going through a rapid test that turned positive; This is a spontaneous report from a contactable consumer  reporting for himself.  A 53-years-old male patient started to receive bnt162b2 (BNT162B2; Lot # EK5730) vaccine , intramuscular in the left arm  on an unspecified date at single dose  for Covid-19 immunisation .  Medical history included hypothyroidism from an unknown date.  Concomitant medication included levothyroxine sodium (SYNTHROID).  The patient  stated that he does get test for the virus twice weekly. He did end up getting the Pfizer, the first round of Pfizer vaccine a week ago. The patient had a test, a virus test before, a swab test afterwards, both were negative but by Christmas eve the patient started getting, what he thought was side effect of the vaccine and he ended up going through a rapid test  and it turned out he was positive for the virus.
As per nursing notes documented on 4/22/21 at 6:17 am, resident observed in bed with no respirations at around 5:10 am.  Patient completed a 7 days course of Levaquin for UTI. Patient was on Vancomycin IV 750 mg every 12 hours and Zosyn 2.25 mg every 6 hours for possible pneumonia.
This spontaneous report was received from a physician via a company representative concerning a 74 year old female patient. The patient had no pertinent medical history and no drug reactions or allergies. On an unknown date in June 2010, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). There was no concomitant therapy. Approximately on an unknown date in 2010 (reported as within the last 10 days after vaccination), the patient developed full blown case of shingles around her breast. The patient sought medical attention (office visit). The patient was treated with an unspecified antiviral medication. No lab test was performed. The patient was recovering from full blown case of shingles around her breast. The relatedness for the event was unknown for ZOSTAVAX. VZVIP packet faxed. Additional information has been requested.
Initial unsolicited report received from a Physician on 29 June 2016. This case involves a male patient (age was not reported) who was vaccinated with a dose of MENACTRA (batch number- U5180AA, expiry date, site and route of administration was not reported) and ADACEL (batch number- U5316AA, expiry date, site and route of administration was not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date, same day following the vaccination, the patient had experienced eyes rolled back. Laboratory investigations and corrective treatment were not reported. The patient outcome was reported as unknown. List of documents held by sender: none.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. On 24-JUN-2014, the patient was vaccinated with GARDASIL (0.5 ml, lot#J011272, expiration date: 21-APR-2016) intramuscularly which underwent a temperature excursion. No adverse events were reported. At the time of the report action taken with GARDASIL was unknown. This is one of several reports from the same source. Additional information has been requested.
Extreme GERD, chest pain, palpitations, tinnitus, new onset high blood pressure, fatigue.   Prescribed Nexium and Metoprolol
Pruritic and erythematous rash at the injection site about 2 inches in diameter.
Weakness in legs. Left side of her body was numb and throbbing with pain. Felt like swelling in her throat along with bad headaches and chills. Chest pain on the left side and couldn't breathe norm.
Approx 24 hours after Menactra vaccine was given sub Q. left arm, injection site developed redness, swelling and discomfort. 48 Hours post injection site was 50mm erythematous, warm to touch, swollen and arm was painful when moved. Treated with hydrocortisone cream 1% TID and Motrin 600mg TID.
"Acting funny since shots". Fever up to 104.2, irritability, loss of appetite, rash on forehead. Symptoms still present.
Patients arm was red, hard, hot itchy in a 3 inch circle. Patient went to Dr and received antibiotics.
Pain at injection site; High fever; Body shaking; Headache; Chills; Sweats; Felt very nauseated like a had a hang-over for a week.; Blistery rash on my back; This is a spontaneous report received from a non-contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: FL9266), via an unspecified route of administration in the left arm on 13Feb2021 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications included blood pressure medication, thyroid medication and estrogen (MANUFACTURER UNKNOWN) for an unspecified indication from an unknown date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EL9262), via an unspecified route of administration in the left arm on 23Jan2021 at 09:30 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 13Feb2021 at 20:00 (after 13 hours of second vaccination), the patient experienced pain at injection site, high fever, body was shaking, headache, chills and sweats which existed for 14 hours. On an unspecified date in 2021, the patient felt nauseated like a hangover for a week. The patient also had a blistery rash on her back that was scabbing over at the time of this report. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of pain at injection site, high fever, body shaking, headache, chills, sweats were recovered on 14Mar2021; nauseated was recovered on an unspecified date and blistery rash was not recovered at the time of this report.  No follow-up attempts possible. No further information expected.
I woke up with chills and severe shaking. My temperature at the time was 102.5. That continued through the night and I wasn't really able to get back to sleep and I got up and took a shower later and I was still shaking and my fever was still there and teeth were chattering violently. I went to Urgent Care Facility (my primary care doctor is through them). I was having a little tightness in my chest - difficulty breathing. They did a quick exam and took my temperature and I think it was still either 102.5 or 102.6 and they did a PCR COVID test -  negative. No treatment. They said I could take Tylenol as needed and refrain from dairy products. I went home and took Tylenol and fever went down a bit. The next day, I noticed I had swelling in leg and a little bit of redness. So I called in and went back to the same place (urgent care facility) and fever was up again and the swelling was getting worse rapidly and very red (right leg) - just below the knee. They were concerned at the rate it was developing. They thought it was a blood clot or cellulitis and so they sent me to ER - Hospital and they went and did a ultrasound assessment of my veins and didn't see any evidence of a blood clot and also took samples for cultures. And the conclusion was it was Cellulitis and they put me on an IV antibiotics - two night stay. I went in on the 30th and the first and the afternoon of the 2nd, I was discharged. When I was released, I was continued on the same antibiotic but orally - four times  per day - Cephalexin - 500 mg capsules. That resolved my symptoms. The swelling went down and the fever went down as the result as infection resolving. I had a follow up with my primary care physician on July 8th for that.
Patient reported history of fainting before/after vaccination in the past. Reported Phobia of needles. Patient was fine after vaccination and was let into the lobby to wait 15 minutes for observation. After about 10 minutes, patient had fainted. Patient was in chair and supported to not fall out of the chair. Patient was given water and vomited about 5 minutes later. Gave icepack and observed for another 30 minutes with no incident.
Child developed respiratory symptoms that have included severe shortness of breath and coughing episodes, per mother, continues to have respiratory distress at night requiring the use of paramedics and 02.
Information has been received from a physician concerning a patient who on an unknown date was vaccinated subcutaneously with a dose of PNEUMOVAX 23 (dose and lot # not reported). On an unspecified date the patient experienced pneumococcal pneumonia with bacteremia and was hospitalized. Unspecified treatment was given for the patient. At the time of reporting, the patient's status was unknown. Pneumococcal pneumonia and bacteremia were considered to be disabling. Additional information has been requested.
PATIENT EXPERIENCING SWELLING UNDER ARM LOOKS LIKE A LUMP.  PATIENT STATES IT HURTS AND IS SORE.  WILL ICE AND TAKE NSAIDS
Information has been received from a nurse practitioner concerning a 17 year old female who on 04-JUN-2007 was vaccinated IM with a 0.5 ml first dose Gardasil. On 04-JUN-2007 the patient fainted and hit her head. Unspecified medical attention was sought. Subsequently, the patient recovered from fainting. This is one of several reports received from the same source. Additional information has been requested.