chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 4/9/99, the infant received her 2nd injection of Engerix-B. On 5/11/99, the infant received her 1st dose of rotavirus vaccine (Rota Shield, Wyeth Labs) and inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and her 2nd injection of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Acel-Imune, Lederle Labs) and Haemophilus influenza type b conjugate vaccine (Hib-Titer, Lederle Labs). The physician reported that the infant began vomiting and having diarrhea on 5/16/99, 37 days following receipt of Engerix-B and 5 days following receipt of other vaccines. On 5/17/99, she developed "colicky" abdominal pain and bilious emesis. She was taken to the local ER where evaluation was "non-diagnostic". The infant was hospitalized. Later on 5/17/99, she became more "colicky" and passed a bloody stool. She was transferred to a tertiary care center. A series of upper GI (GT) x-rays were negative. Contrast enema revealed intussusception, which was reduced by the enema. The physician reported that the infant recovered. The infant's attorney reported that the infant was lethargic on 5/15/99. On 5/16/99, she "screamed repeatedly and exhibited stomach rumbling". In the ER on 5/17/99, a stool specimen was reportedly positive for occult blood. Her temperature was reportedly 99.3F and her fontanelles were "slightly sunken". The infant was administered unspecified IV fluids. The attorney reported that the infant developed intermittent abdominal pain and fussiness and was seen in the local ER on 5/23/99, 44 days following the administration of Engerix-B and 12 days following the other vaccines. The attorney alleged that "the infant experienced episodes of screaming and pain for a period of almost a year." The reports were considered to be life-threatening and involved persistence of significant disability or incapacity. The infant reportedly recovered from intussusception. Outcome of the screaming, abdominal pain and fussiness were not specified.
Information has been received from an approximately 20 year old female with no drug allergies and no medical histories, for GARDASIL, a Pregnancy Registry product, who "about one month ago", in approximately February 2011, was vaccinated with a first dose of GARDASIL (therapy route and lot # not provided). There was no concomitant medication. A few days after receiving her first dose of GARDASIL she developed a "weird rash", described as hives over her whole body (the hives moved from site to site). The rash has continued to the present even the patient used an "anti-itch" cream (cream unspecified). Two weeks ago, on approximately 17-MAR-2011, the patient also developed a "strep throat" which was treated with the antibiotic amoxicillin. The patient was late for her period and yesterday, on 30-MAR-2011s she did a urine pregnancy test and was told that she was pregnant. Her last menstrual period started from 01-FEB-2011 and ended on 05-FEB-2011. Her estimated delivery date was 08-NOV-2011. At the time of reporting, the patient's outcome of "strep throat" was unknown. Patient sought unspecified medical attentions. Follow up information has been received from the physician concerning the 20 year old female patient who on 02-MAR-2011 was vaccinated with the first dose of GARDASIL (lot number 663558/0819Y, exp date 10-OCT-2011). Additional information has been requested.
I started getting severe headaches and with that comes nose bleeds every other day. I also got my menstrual period. I have had it for 2 months it started with a lot of bleeding and now I just spot. The nose bleeds are severe.
I got symptoms of tiredness, fatigue, runny nose, and dry cough. On the second day, I got a positive COVID-19 test. My symptoms progressed. I was prescribed Paxlovid. My first week was the worse and the second week, I started feeling better. The runny nose and cough lasted about one month.
Parent called office 10/12 hours, to report that patient had not been herself since immunizations given.  And 06/11/03 had slept the entire day and night-wouldjust go back to sleep when aroused-did take 2 bottles but just fell asleep after.  Seemed perfectly normal 06/12/03, no fever.
Irregular, heavy periods post vaccination.  Repeat of flu-like symptoms from after second vaccination: hurt all over, backache, as if a repeat of the second vaccine side effects are linked to menstrual cycle, now.  Seem to be coming down, reducing over months, but still significant at third cycle after second vaccine.    Also very tired/exhausted most of the time since second vaccine (entire month, regardless of cycle).  I also had a systemic allergic reaction to my second vaccine:  hives, shaking, dizziness, feeling like was going to faint.
Mother of pt states right leg was swollen and red the morning of 3/30/00. She also states he didn't have a fever nor was he crying. She took him to the MD's office on 3/30/00, MD encouraged mother to give Motrin every 4 hours.
History of recent admission at Hospital from 08/14/2021 to 08/24/2021 because of a COVID-19 infection leading to respiratory failure and bilateral pneumonia.  Discharged on Augmentin and Flagyl. After reaching home, she called 911 again because of worsening shortness of breath and EMS found her to be only saturating 60% on room air.  They put her on a non-rebreather where she was saturating around 85% to 86%.  In the ER, she was put on the BiPAP.  ABG done on the non-rebreather showed a pH of 7.328, pCO2 67.6, and a pO2 of 59.6.  Repeat ABG on the BiPAP is still pending as we speak.  CT angio of the chest was done in the ER, the preliminary results of which is showing no PE but showing bilateral pneumonia, especially in the left upper lobe and left lower lobes.  Patient was started on Zosyn and vancomycin and the hospitalist service was called for admission. Admitted on 8/24/21 due to being very symptomatic with occasional chest pain when she coughs. Placed also on dexamethasone. discharged on 9/14/21.
Within an hour, began itching, body aches, fatigue.  1/4/20 had full menstrual cycle with cramps (have not had one in 12 years due to mirena) 1/9/20 wide spread hives, rash, swelling of ears, tongue, nose. Began steroids. 1/15/20 swelling and rash began again, went to ER. Raised steroids.  High emotions, brain fog, confusion.
Severe pain in her left leg; the pain is becoming increasingly difficult; Severe pain in her left leg; the pain is becoming increasingly difficult; This is a spontaneous report from a contactable consumer (patient's husband). This is the second report out of two split reports. A 79-year-old female patient received bnt162b2 (formulation: solution for injection; COVID-19 Vaccine manufacturer: Unspecified; NDC number, UPC number, expiry date and Lot number: Unknown), dose 2 via an unspecified route of administration, administered in left arm (at the age of 79 years) on 18Apr2021 as dose 2, single for covid-19 immunisation. Medical history included heart issues from an unknown date and unknown if ongoing and too many dimensions (not clarified) she had heart issues, mainly heart issues. The patient's concomitant medications were not reported. The patient historical vaccine included BNT162B2 dose 1 (lot number: ER8732) on 28Mar2021 for Covid-19 immunization at the age of 79 years. The patient's husband reported that his wife had the same shots, at different times of Pfizer and we were just beginning to explore what the issue was. She had severe pain in her left leg. After her second shot on an unknown date in Apr2021. Patient had been dealing with her primary care doctor. She had doppler on her leg because she had the similar pain in her left leg and it's not been resolved yet. This was an ongoing thing. So, she had now taken a doppler and the pain is becoming increasingly difficult, and she is in the process of evaluating what this is and gone down the emergency room the next day. The patient underwent lab test which included Doppler scan with unknown result in 2021. The outcome of the event was not recovered.   Information on the lot/batch number has been requested.
3 hours past receiving vaccines started with fever & vomiting times 3 episodes. Given TYLENOL by parent/ rash/hives on face during the night. Fever up to 102 degrees. No rash/hives on rest of body. Instructed to take child to doctor.
the next day the patient called to report experiencing severe arthralgia, upper extremity weakness, myalgia and motor weakness; the next day the patient called to report experiencing severe arthralgia, upper extremity weakness, myalgia and motor weakness; the next day the patient called to report experiencing severe arthralgia, upper extremity weakness, myalgia and motor weakness; the next day the patient called to report experiencing severe arthralgia, upper extremity weakness, myalgia and motor weakness; This spontaneous report as received from a physician refers to a 65-year-old female patient. The patient's concurrent conditions included asthma, arthritis, anxiety, depression, hyperlipidaemia and allergy for iodine contrast medium. Her historical drug included cephalexin (KEFLEX), for which she had an allergic reaction. The concomitant therapies were not reported.  On 22-JAN-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), lot # S005856, expiration date 03-DEC-2020, intramuscularly for prophylaxis (dose and frequency were not provided). On 23-JAN-2020, (also reported as on the next day), the patient experienced severe arthralgia, motor weakness, upper extremity weakness and myalgia. The patient received treatment with unspecified analgesia on an unknown date in January 2020. The outcome of the events was unknown (also reported as present status stable).  The causality assessment was not provided.
pt recvd vax & c/o having a sz 1MAR94; taken to hosp ER; seen by MD;
pt began to have difficulty breathing following vaccination. Ems was called and an EpiPen was administered
48 patients have received an expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients have received an expired vaccine) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients have received an expired vaccine). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients have received an expired vaccine) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Preparation and administration error. Patient received 180mcg of Pfizer COVID-19 vaccine IM.
A report was received from a health care professional on 11/19/03 concerning a female vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Follow up information received from a health care professional indicated that an 88 year old vaccinee received Fluvirin on 11/10/03. On 11/12/03 the patient also experienced a productive cough and lung congestion. These events in addition to the sore throat resolved on 11/19/03. Follow up pending.
PATIENT REPORTS BECOMING VIOLENT YESTERDAY AFTER RECEIVING THE VACCINE. STATES HE BROKE AN END TABLE AND IS NORMALLY NOT VIOLENT
Since 2 or 3 weeks ago the asthma has intensified, her asthma medicines are no longer; tachycardia; she was cheerful , now she does not smile, is sitting, has no desire or strength to do anything; cough; can barely walk, has difficulty walking; has fatigue/tiredness; right shoulder is purple; was dizzy , felt and injured her shoulder; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), GAIT DISTURBANCE (can barely walk, has difficulty walking), DIZZINESS (was dizzy , felt and injured her shoulder), ASTHMA (Since 2 or 3 weeks ago the asthma has intensified, her asthma medicines are no longer) and TACHYCARDIA (tachycardia) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039132IM) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Asthma. Concomitant products included GABAPENTIN and PARACETAMOL (TYLENOL) for Arthritis, MONTELUKAST and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced DIZZINESS (was dizzy , felt and injured her shoulder). On 04-May-2021, the patient experienced ARTHRALGIA (right shoulder is purple). On an unknown date, the patient experienced COUGH (cough), GAIT DISTURBANCE (can barely walk, has difficulty walking), ASTHMA (Since 2 or 3 weeks ago the asthma has intensified, her asthma medicines are no longer), TACHYCARDIA (tachycardia), FEELING ABNORMAL (she was cheerful , now she does not smile, is sitting, has no desire or strength to do anything) and FATIGUE (has fatigue/tiredness). At the time of the report, COUGH (cough), GAIT DISTURBANCE (can barely walk, has difficulty walking), DIZZINESS (was dizzy , felt and injured her shoulder), ASTHMA (Since 2 or 3 weeks ago the asthma has intensified, her asthma medicines are no longer), TACHYCARDIA (tachycardia), FEELING ABNORMAL (she was cheerful , now she does not smile, is sitting, has no desire or strength to do anything), ARTHRALGIA (right shoulder is purple) and FATIGUE (has fatigue/tiredness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also include Blood pressure medication Diabetes Medication,Pills for sleeping.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: follow up on 04 JUNE-2021 new event were updated
Received Hepatitis A in left arm 12/5/03. Started with swelling, itching and redness. Responded to Benadryl and compress. 12/8/03 noted left arm warm, firm and blotchy redness. Treatment: local care and Benadryl PRN. Reaction lasted 5-7 days.
Given influenza vaccine on 10/6/10. On 10/7/10 and for 4 days following vaccine at the injection site there was intense itching, redness, swelling pain, felt a knot and warm to touch. BENADRYL cream applied to site of itching and ice pack for warmth and pain. Pharmacy stated no thimerosal in single use vial.
The vaccination was a flu shot; it is unknown to me the exact type, lot, manufacturer. Pharmacy staff (pharmacist and tech) came to my work place and injected the flu shot around 11:30AM. By the end of my shift (3PM), I began to feel my chest compress. My eyes began to swell and had a discharge. By the time I got home, around 3:40PM, I had a 100.4 F temperature, body aches, sore throat and headache. I took 50mg of Benadryl and 2 Advil capsules. Before bedtime, 10PM, my temperature was 100.5 F. I decided not to take any more Advil to see if the temperature would lower on its own. At 3AM, I woke up with a temperature of 100.4F and lips swollen. I took two Advil capsules and 50mg of Benadryl. I woke up at 8AM with a headache and took two more Advil capsules.  Due to having Keratoconus on both eyes.
The first day I was in a lot of pain. They gave me Benadryl but had to come home from work because it was still painful. Had fever. Slept. Achy and wheezing. Then a few days after my leg swelled up bad. Doctor told me to go to ER. My calf had swelled to 18 inches in diameter. No blood clots found. Doctor gave me things to look for to keep an eye out for blood clots. Gave me more meds and reduce my swelling. My arm was now permanently stiff and couldn't lift anything. Doctors were trying to reduce swelling. Wheezing and cough continued and also my regular breathing was labored. Treating still with Furosemide. Heart, lungs, joints still swollen via CT scan. Checked glands and they were swollen. Headaches and blurry vision. Took prescription for that. Potassium treatment now because of all of the fluid reduction. Joints swelling and legs swelling. Varicose veins now. My breathing has gotten worse, the pain is constant in my back and arm. The lymph nodes are still swollen. The Doctor (cancer research) had a Zoom meeting with me and helped determine what medications are best for me. Also, they sent me to the bone/joint specialist because of the swelling in case there was damage to the nervous. She only found that it is causing arthritis.
1st 24 hours, arm pain, tiredness, slight dizziness. At 29 hours post vaccine, nausea, chills, slight fever, headache started. At 32 hours post vaccine severe vomiting and diarrhea started and continued for 6 hours.  During vomiting had uncontrollable leg shaking and elevated heart rate. At 48 hours post vaccine, very weak, headache, dizziness increasing - took Advil, 1 does in am, 1 does in PM, only helped headache 5 days after vaccine still dealing with severe dizziness and ringing in ears, making it hard to walk, sleep.
Fever; Headache; Loss of taste; Coughing; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache), AGEUSIA (Loss of taste) and COUGH (Coughing) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included Coughing since an unknown date. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 31-Mar-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache), AGEUSIA (Loss of taste) and COUGH (Coughing). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), HEADACHE (Headache), AGEUSIA (Loss of taste) and COUGH (Coughing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Around 12-24 hours post vaccination, symptoms developed at injection site: redness, warmth, swelling, and pain. The redness was rash like in appearance and extended from the shoulder area to the elbow.  The area continues to have redness, warmth, swelling, and pain today.
intern pharmacist did not check for egg allergy and administered  the vaccine to the patient. patient reported eye swelling. epi-pen was administered and patient returned to normal.  no other complaints besides fatigue in early evening.
This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for six patients. This is third of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) via an unspecified route of administration on an unspecified date at a single dose as vaccination. Medical history and concomitant medications were not reported. The patient experienced severe anaphylaxis with vaccination on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021003207 same drug/event and different patients
Following 03/04/2021, my arm was sore with red around the injection area. Slight headache the following day. I begin to notice a itchy rash and blotchy  spots on my body. Mainly the concern was the extreme redness and eczema-like looking rash on my forearms. I tried to treat the issues at hand with over the counter Benadryl. I took Benadryl along with aloe vera cream and ibuprofen to assist the irritation. Once I was unable to get directly into my doctors office, I went to an UTC, whom assisted me. I was then given a prednisone shot and  a series of prednisone for five days.
Dramatic swelling, redness, browny edema of the whole arm from tip of shoulder to elbow and low grade fever. No vomiting or chills. Local area of temperature and warmth. Had significant pain after administration of vaccine.
arms a little sore; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. Medical history included blood pressure (abnormal). Concomitant medication included verapamil for blood pressure. It was reported that the patient got to receive the first one on the 8th. She did not have any symptoms than her arms a little sore. She got her second dose of Pfizer shot on the 28th and then she guessed the first. Outcome of the event was unknown.   Information on lot/batch has been requested.
COVID Arm Cutaneous Hypersensitivity Red, raised area 2?x4? at injection site Sore, itchy, warm to touch
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a four-year-old male. Neither medical history nor concomitant medication was reported for this patient. The product expired on 26-Jan-2011. On 27-Jan-2011, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
no adverse events to report.  Patient was accidentally given Moderna for 2nd dose when she'd gotten Pfizer for the first.
pt recvd vax;later got up & seemed to just sink to the floor;face was pale;BP 90/60; grandma said she hit back (heart rate 100,resp 24) of head; nothing observed; no N/V; feeling better after about 15 mins;
blanched patch @ inject site; raised 1/4 cm x 1/2 cm; no redness, warmth, pain or induration; almost like a small pox scar; edges are not smooth; 9OCT92 follow up; area described as tB skin test just given; not absorbed; did recover;
"Blacked" out, woke unable to speak words and was paralyzed from neck to feet. When the EMT arrived, I was able to try to barely say one syllable words.  I was taken to ER at hospital and a CT scan was taken. (Stroke or TIA was ruled out) No one could explain why the paralysis was on both sides of my body. Dr. mentioned a possible allergic reaction. After a few hours the paralysis began to subside, and I was able to speak in full sentences.
I?ve had total loss of hearing in my left ear. It?s been two and half weeks
Broke out in red bumpy rash on face.  Took 1 Benadryl immediately upon noticing the symptoms.  Was gone by the next morning.
Patient was under the age of 16 and received the vaccine.  It was a medication error not an adverse drug event
Fever to 102 for 3 days post-vaccine.  Rash developed 6 days post-vaccine (slightly raised erythematous maculopapular rash mostly on back, spreading to torso, nonpruritic).  Another fever developed 8 days post-vaccine, to 103.5.  Rash improved but pt became more irritable and seemed to have pain when walking.  Fever lasted 24hr.  Mom concerned that "pt not himself".  By day 11 post-vaccine pt improving with decreased irritability and pain.