chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer-BioNTech COVID-19 Vaccine EUA: during follow-up encounter with allergy clinic patient reports metallic taste within thirty minutes of vaccination. Two hours later developed headache and fatigue. Two days later developed lower extremity swelling, low heart rate (52 beats per minute), blister on neck/upper back, leg pain, neuropathy, and left arm bruising where immunized. Six weeks later symptoms are beginning to resolve. Patient advised to continue current medications for reaction.
Desaturation to 8 and bradycardia to 55. Required PPV to return to baseline. Noticed that finger tips and soles of feet as well as groin turned a bright, vivid red and palms were white. This reaction dissipated within 1 minute and infant color returned to normal.
lot of itching in her arm; lot of pain on the site of shot; she has like symptoms; Experienced pain in her arm and it would not go away; the pain goes to her back; A bump in her chest; feeling really hot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "lot of itching in her arm"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "lot of pain on the site of shot; she has like symptoms"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Experienced pain in her arm and it would not go away"; BACK PAIN (non-serious), outcome "unknown", described as "the pain goes to her back"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "A bump in her chest"; FEELING HOT (non-serious), outcome "unknown", described as "feeling really hot".  Additional information: Patient had a lot of itching in her arm and she was feeling, Patient was having a lot of pain on the site of shot. Patient experienced pain in her arm and it would not go away, the pain goes to her back; A bump in her chest; feeling really hot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe cough, 102 fever, chills, diarrhea, flu like soreness, sick to stomach, couldn?t sit up, felt generally horrible like I felt with covid back in October. Hoping tomorrow will be better.
Rash on thighs appeared a few hours after shot. Rash on upper arms, ankles, elbows, thighs, and stomach, mild/moderate, appeared next day. Rash at injection site worsened over a few days. Rash side effects were not experienced in previous Pfizer booster (taken with flu shot) or previous Moderna two shot doses. Other side effects including fever (101F), aches, chills, nausea, fatigue, and lymph node swelling were experienced after all COVID shots. Reported to doctor over email message. Doctor recommended antihistamine at bedtime and suggested reaction was likely hypersensitivity. Antihistamine (Benadryl) taken 2-4 times daily. Antihistamine lessened itching and inflammation. Currently on day 4 and still have rash, but it appears to not be getting worse.
She states the "infant did not seemed bothered" and the mother wiped his eye with a bib./ She did not note any redness in his left eye.; the medicine started to squirt in the patients left eye; the medicine started to squirt in the patients left eye; The medicine sprayed from the "neck of the bottle, where it twists"/ she belives there may be a small hole in the bottle /it was a "pinpoint" and she cannot see the hole /Liquid was leaking out once pressure was applied.; As she was giving ROTATEQ/ The medicine sprayed from the "neck of the bottle, where it twists"/ she belives there may be a small hole in the bottle /it was a "pinpoint" and she cannot see the hole /Liquid was leaking out once pressure was applied.; This spontaneous report was received from a nurse and refers to a 6 month old male patient. The patient had none medical history, drug reactions or allergies and concomitant medications.  On 30-JUL-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dose, orally, lot # 1660989, expiration date: 15-APR-2021 ( dose number was not reported) for routine prophylaxis. While the nurse was giving the vaccine to the patient, the medicine started to squirt in the patient's left eye. It was reported that the infant did not seemed bothered and his mother wiped his eye with a bib. The nurse did not note any redness in his left eye.  The nurse believed there might be a small hole in the bottle. She did not notice any issues with the device until she applied pressure. The medicine sprayed from the "neck of the bottle, where it twists". The foil wrapper/sleeve was not sticky or wet when it was opened. There was no damage to the foil pouch. There was no product residue in the carton.  The outcome of accidental exposure to product via eye contact was unknown.
Patient administered ROTARIX on 5/26/11 at 2 mos well child visit. On 5/28/11 small amount of blood noted in stool and has persisted. Now has some diarrhea. No other symptoms. Child feels well.
Case number PHEH2014US020661 an initial spontaneous report received from a nurse on 13 OCT 2014. This report refers to a 02 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413601) intramuscularly on 13 OCT 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Subsequently post vax, the pt experienced arm tingling that extends to his hand. The pt also reports a loss of strength in the hand.
had sz on 30AUG93 & 1SEP93 had EEG done WNL; started on Tegretal by MD;
Dizziness. Vertigo.  This is 17 days  after the first shot. Don't believe this is normal
No adverse event; patient tolerated vaccine well. Vaccine error (booster dose given early).  Booster given after 4 months and 20 days after 2nd dose rather than 5 months per CDC guidelines.  Alert in database showed that patient was due for booster but was not yet due until 2/7.
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 POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 1:44 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 1:44 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, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (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 43.11. Concomitant products were not provided. On 14-Feb-2021, Excursion time were 09 AM, 10 AM, 11AM, 2PM,3PM, temperature were 32, 32, 32, 35, 35 total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  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 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.
1 week post: Right arm injection site became itchy, swollen, red, with a histamine rash and hardened nodule. Lymph nodes at arm only slightly swollen/tender.
Extreme chills, fever 101.5, muscle aches started approx 12 hrs post vaccination. Unable to complete activities due to symptoms
3 raised excoriated, unroofed papules in (R) medical thigh with surrounding erythema/induration about 4 cm x 2 cm no tenderness to palpation (+) itch.
p/vax pt devel a herpes zoster like rash;pt sought unspecified medical attention;
CPhT administered 0.25ml of Pfizer instead of 0.3ml for a booster shot. Patient was notified of error and did not want to come back in for the additional 0.05ml dose that was shorted.
test positive with COVID-19 Virus; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (test positive with COVID-19 Virus) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (test positive with COVID-19 Virus). At the time of the report, SARS-COV-2 TEST POSITIVE (test positive with COVID-19 Virus) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Med asst prepared incorrect vaccine, flu 0.5 ml instead of 0.25 ml and I gave it.
Left armpit lymph nodes swollen and painful. Started as tender to touch on the morning of 12/20/20 and became increasing painful throughout the day and by end of day throbbing. On 12/21/20 throbbing has stopped but still painful to arm movement. Occassional tingling down the left arm.
Patient experienced mild puffy eyes. She reported developing a red bumpy rash on her forearms, stomach and back of knees. Symptoms started one day after vaccination on 01/08/2021. To my knowledge, patient did not use anything for treatment.
PATIENT'S ARM BECAME VERY SWOLLEN, PAINFUL, ITCHY, AND RED ABOUT 4-6 HOURS AFTER DOSE WAS GIVEN. SWELLING GOT WORSE OVERNIGHT.
Cold sweats, joint pain. fever, Arm soreness with redness, swelling warm to touch
pt devel rash p/discharge from hosp;seen by MD referred to MD dx r/o PUPP unlikely secondary to rubella vaccine;rx DPH & topical high potency temovate cream;
Left arm injection: Left nipple pain in 6 hours: Pain in both nipples after 24 hours: swelling in area behind nipples: Pain and swelling has continued to this date.
Urinary Tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary Tract infection) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary Tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary Tract infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This case was received on 13 May 2009 from a consumer. A 41 year old female patient received ACAM2000 (lot number unknown) in her left arm and anthrax vaccine (manufacturer and lot number unknown) in her right arm on 02 May 2009. Nine days after vaccination the patient noticed increased redness and swelling around the ACAM2000 vaccination. The patient also experienced fever, an extremely bad headache, abdominal discomfort and mild cough. The redness progressively increased to approximately 3 inches in diameter with a 1 inch wide red streak radiating laterally around arm to under the armpit. The patient also reports mild lymphadenopathy. The patient was advised to see a local healthcare provider for evaluation of possible cellulitis. List of Documents held by Sender: None.  7/7/09 ED  records received DOS 5/2/09. Assessment: Cellulitis, reaction to smallpox vaccination. Patient presented with loss of band-aid covering immunization site. Site demonstrated 'redness and erythema', red streaking, warm and hard, headache.  ICD-9 Codes: V5989, V5889
negative [antibody test]; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (negative [antibody test]) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (negative [antibody test]). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (negative [antibody test]) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Antibody test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.   This case was linked to MOD21-060893 (E2B Linked Report).; Sender's Comments:  MOD21-060893:wife
Initial and follow up information has been received for the  pregnancy registry for GARDASIL from a physician and a nurse concerning a 24 year old female with a past history of two previous pregnancies (1 full term delivery and 1 spontaneous abortion in the first trimester) and an allergy to AMOXYXILLIN who on 04-OCT-2007 was intramuscularly vaccinated with her first dose of GARDASIL (lot#658563/1063U). The patient received her second dose of GARDASIL (lot#658563/106U) on 29-NOV-2007. The patient was pregnant with an LMP of 30-Sep-2007, at the time of vaccination. Concomitant therapy included daily prenatal vitamins. No adverse events were reported. The patient sought unspecified medical attention by contacting the physician's office. On 14-Dec-2007 an ultrasound was performed to establish the expected delivery date. The patient is due 05-Aug-2008. On 21-Feb-2008 a MSAFP (alpha fetal) was performed, results were negative. the patient tested rH negative on an unspecified date. On 06-May-2008, the patient was given a single dose of globulin, immune. On an unspecified date, the patient was treated for an ear infection with an unknown dose of azithromycin for an unspecified period of time. The patient delivered a normal female baby on 03Aug2008 (39 weeks 5 days from LMP). The baby had APGAR scores of 6 and 9, weighed 9 lbs 8 oz, 48.3 cm long, and a head circumference of 37.0 cm. the patient had no complications during pregnancy or labor. Additional information is not expected
pt recvd DTP/HIB 25SEP92 around 9AM; mom reports giving APAP aobut 11PM & pt going to sleep around 12AM; pt awoke 2, 4, & 430AM; parents awoke 830-9AM pt was not breathing; Father reports secretions from pts mouth; family called coroner;
At approximately 20 mins after vaccination, patient reporting complaints of dizziness without N/V.  Vitals HR  76, RR 16, BP 122/82, O2 96%.  Patient reporting she has only had coffee this AM and was given peanut butter crackers.  No complaint of vision changes or SOB. Patient left site at 10:30 AM.
The pt reported that he received his primary SPV in his upper left arm on 29Aug13. He was in his normal state of good health at that time. On 9/8/13 he reported that he had a diffuse, generalized, red, papular (1-3 mm red papular lesions), itchy rash "from head to toe". The rash covered the pt's neck, chest, abdomen, back, arms and was less concentrated on his legs. There were no lesions on the pt's genitalia, in his mouth, on the palms of his hands or the soles of his feet. The pt stated that he thought he had a low grade fever but otherwise he had no complaints (headache, N, V, malaise, generalized body aches). Of note, the pt also reported that he took amoxicillin from Aug 30-Sep 8 after having his wisdom teeth removed. A review of the medical record noted that the pt reports having 3 episodes on 9/4/13 lasting about 10 minutes each relieved with belching. The pt did not note SOB, radiation of the pain, palpitations, N, V, diaphoresis or that the pain was affected by position. The initial EKG was noted to be NSR with ST elevation probably due to early repolarization. The pt was seen in cardiology on 9/6/13; his EKG showed NSR and it was opinioned that this epigastric pain was non-cardiac. On 9/9/13 the pt was seen by his PCM for his rash which was treated with epi 0.3mg, 125mg SOLUMEDROL IV and 25mg BENADRYL po. On 9/10/13 the pt was seen by his PCM who reported that the rash had not progressed and was slightly improved. Additionally, the pt had labs drawn (see lab section). The pt reported complete resolution of his rash on 9/11/13.
Patient came in with 2 other female relatives for first covid vaccine dose.  Brother acted as interpreter;  All women requested Moderna first dose.  Brother was required to leave room prior to women being able to expose their arms per family.   Pt was vaccinated, however she was discovered to be 17 yrs old after, even though she presented with the paperwork for an adult of age 18.
COVID-19 positive 12/22/2021 after being fully vaccinated and boosted.
Chills after the shot (3 days after the shot)  I fell because loss of balance and weakness'  evening just before bed time. Fell in bathroom  could not get up due to a loss of strength.  M.S. effects my right leg.
Information has been received from a registered nurse on 08/15/2001 concerning a female with no known drug allergies who "about four years ago" was vaccinated with a second dose of varicella vaccine. There was no concomitant medication. It was reported on 08/15/2001 that recent titers did not show seroconversion. The pt sought unspecified medical attention. Additional info has been requested.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test/COVID 19 Pneumonia; This is a spontaneous report from a contactable physician. A 79-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), the first dose via intramuscular on 14Jan2021 (Lot Number: EV1685, at age of 79 years old, no pregnant) at a single dose and the second dose via intramuscular on 04Feb2021 (Lot Number: EL8982, at age of 79 years old, no pregnant) at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. No other vaccine in four weeks. On 05Mar2021, patient was hospitalized with severe COVID 19 Pneumonia requiring 100% BiPAP. Antibody to SARS-COV2 not detected. AE resulted in: Hospitalization, Life threatening illness (immediate risk of death from the event), hospitalization: 8 days. Treatment received: Steroids. The patient did not have COVID prior vaccination. Covid test post vaccination on 06Mar2021: covid test type post vaccination: Nasal Swab. Covid test result=Positive. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, causality between events vaccination failure / covid-19 pneumonia and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,) cannot be excluded.
There was no actual adverse event, this was an accidental 4th dose given.  When adding this dose into the patient's online immunization registry, it was found that patient had previously received 3 doses of Pfizer - 01/04/21, 01/25/21, & 08/27/21.  Which makes the Moderna vaccine from today her FOURTH dose which is not a current recommendation at this time (since she is not immunocompromised).  I tried to reach out to the patient, but she did not answer her phone or return my call.
This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 25-year-old female patient who received FLULALAVAL QUADRIVALENT (batch number Y9H77, expiry date April 2017). On 12th October 2016, the patient received the 1st dose of FLULAVAL QUADRIVALENT (intramuscular). On 12th October 2016, several hours after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site swelling, injection site warmth and injection site itching. On an unknown date, the outcome of the injection site swelling, injection site warmth and injection site itching were unchanged. The reporter considered the injection site swelling, injection site warmth and injection site itching to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was previously not reported to anyone. The patient experienced itching, swelling and feverish at injection site beginning evening of vaccination with FLULAVAL QUADRIVALENT (left deltoid) at 13:00. At the time of reporting the patient still had local swelling and itching and fever at injection site and the swollen area was the size of small apple.
Within the first 10 minutes I had a sever headache that lasted 2 weeks. A few hours after injection, my left side of neck lymph gland started hurting and has continued to hurt and grow over the past year.  I would report this information through the CDC portal.
72 hours after Pfizer vaccine Adverse reaction and was admitted to hospital with intestinal obstruction. Symptoms: vomiting, abdominal pain/cramping, decreased output from colostomy
3 papules with indurated base at site of varivax vaccine on left anterior lateral upper thigh.
Reddened area measuring 3x5 1/2 cm with raised bump/crusty in center approx size of pencil eraser. Area red, slightly raised and warm-Pt noticed possible reaction on 11-3-07. Site at (L) upper arm.
Pt. was administered the Fluzone HD in an event at an assisted living facility on 10/25/2022. After administration, about 1/2 hour later, the patient started vomiting and feeling light headed. Patient was being monitored by the nursing staff on site.
This spontaneous report as received from a pharmacist via other company refers to a male patient of unknown age. On an unknown date in 2011, the patient was vaccinated with the dose of PNEUMOVAX23 (dose, route of administration and lot number were not reported). On an unknown date, the patient experienced localised rash and swelling around the injection site after receiving PNEUMOVAX 23 in 2011. The outcome of swelling around the injections site and localised rash was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
tells me that his father is "typically pretty sharp" however when he becomes more sick, he becomes more confused
Patient presented to the hospital with worsening shortness of breath and productive cough. He we subsequently admitted for COVID pneumonia.
Patient had a loss of smell and tested positive for covid 1 month after being fully vaccinated.