chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 15 year old daughter with no drug reaction/allergies and no concomitant medication usage who in approximately October 2007, was vaccinated intramuscularly (site not reported) with the 1st 0.5ml dose of Gardasil (lot # not reported).  Three days post vaccination (date not specified), the patient experienced a high fever, a stiff neck, loss of appetite and her eyes were sensitive to light.  The patient was taken to the emergency room but was not admitted.  Lab diagnostic tests were performed and the emergency room diagnosed the patient with a urinary tract infection.  Subsequently, the patient "fully recovered five days later".  Additional information has been requested.
Through the night the pt had an increasing cough (croup like) and a fever of 102. Treated with Tylenol/Motrin and Augmentin.
Inflamed right arm (inner upper arm & elbow area). Looks like cellulitis. Pt denies of fever but tender.
Pt given Tdap, GARDASIL, varicella, Hep A => dizzy x few seconds.  VSS (T=97.8, P=76, RR=20, BP=106/60) => Pt observed for 1 1/2 hours => VSS repeated T=97.9, P=76, RR=20, 108/60 s/p 1 1/2 hr.
I got the shot and still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient got the shot and still got shingles. The patient stated that he/she was told that 2 shots were needed. The patient felt mislead.
pt recv vax 29JAN97 & 2 days later exp itching of the head w/a rash from the top of the head to the back of the neck;took oral DPH w/no improvement;
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 14-SEP-2015 the patient was vaccinated with two improperly stored doses of RECOMBIVAX HB 5 microgram/0.5 mL(lot # J009051, expiration date 26-MAR-2016, dose and route were unknown). No adverse effects were reported. The vaccine was exposed to temperature excursion twice. The total cumulative time was 24 hours and 32 hours. The lowest recorded temperature was 34 Celsius degree. The highest recorded temperature was 48 Celsius degree. The storage criteria of the vaccine and the type of excursion were refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Woke up vomiting - vomited a few times over the course of an hour.  Broken blood vessels (?) on face.
Patient has experienced extreme itching and redness at injection site. The area of redness covers majority of her upper arm and is increasing in size. The patient has been under care of her physician for monitoring and treatment with antibiotics.
One week after the vaccine, the pain was intense on my left side of neck,  my left arm was weak and had burning pain and my scalp was on fire.  Four days later, the blisters appeared.
Rash; Painful arm and arm hurting a lot; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), VACCINATION SITE PAIN (Painful arm and arm hurting a lot), CHILLS (Chills) and PYREXIA (Fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Mastectomy (In Right hand side) and Migraine. Concomitant products included ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Migraine.    On 15-Mar-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 RASH (Rash), VACCINATION SITE PAIN (Painful arm and arm hurting a lot), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, RASH (Rash), VACCINATION SITE PAIN (Painful arm and arm hurting a lot), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-285649 (Patient Link).
Initial unsolicited pregnancy report received from a non-healthcare professional on 22 December 2015. This case involves a 30-years old female patient who was vaccinated with first dose of ADACEL (batch number: U5263AA, Expiry Date: 21 January 2018; dose and site of administration were not reported) via intramuscular route on 22 December 2015. The patient's last menstrual period was unknown, estimated delivery date reported as 02 March 2016 and treatment for infertility was reported as none. The patient's medical history and concomitant medications were not reported. She did not undergo any specific risk factors (e.g.: alcohol, tobacco or recreational drugs). It was a vaccine exposure during pregnancy. Laboratory data was not reported and corrective treatment was not reported. The patient did not experience any adverse event. Documents held by sender: none. Follow up information received from consumer on 15 March 2016. No additional information reported.
Dizziness, Myalgia, NauseaVomiting, weakness, lethargy Dizzy, nausea, vomiting, myalgia, weak, lethargic; resolving.
This spontaneous report as received from a 63 year old male consumer reporting on himself with Multiple sclerosis (MS) and anxiety disorders. On 29-DEC-2010 the patient was vaccinated with ZOSTAVAX (Lot # not reported) subcutaneous. No other co suspects were reported. Concomitant therapies included COPASCON 20 mg, ZANEXIN, FEXORIL, FLOMAX and LEXAPRO. The patient reported that on 04-JUL-2013 he experienced shingles after receiving the vaccine. The patient stated that the shingles were on high right side (front and back), from leg to lower spine region. The patient reported that he had numbness in the same areas, along with shingles. The patient reported that the shingles never got the rash on the skin surface. The patient did not seek medical attention. Treatment was not given for the events. Labs diagnostics were not performed. Additional information has been requested.
pt was inadvertently given 2 doses of pnu-imune, 1 wk apart; Pt had been scheduled to recve 1 dose of pnu-imune & 1 dose of flu vax 1 wk later; pt exp an inject site react;
A 16 year old pt with no pre-existing medical history received an IM, left arm injection of Menactra, lot number U1821AA, on 13Dec05. That night, the parent reported that the pt became disoriented. He also seemed confused the next am and his ear was hurting. There was no illness at the time of vaccination. At the time of this report, the pt had recovered.
Patient came in said she had a high fever over 100. She said after getting Moderna, she was really sick for 6 days. She did not say if she went to the doctor or anything. She said she is fine now but it really made her sick and wanted to let us know. I told her I am glad she is fine now. If she needs to go see a doctor she should; but again she said she is fine and she will if she needs to.
Information has been received from a female receptionist who was vaccinated with a dose of Gardasil. Subsequently the injection site became swollen after a week, "about the size of a half dollar." It was reported that there were "rings around the swelling an it was painful. "Unspecified medical attention was sought. At the time of the report, the patient had not recovered. Additional information has been requested.
This spontaneous report as received from a pharmacy technician refers to a female patient of unknown age who was as inpatient for an unspecified reason at the hospital. On 11-APR-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # J010332, expiry date: 14-JAN-2015) in her upper arm for an indication reported as 'age appropriate'. On 11-APR-2014 the patient experienced cellulitis. It was unspecified by the pharmacy technician if hospitalisation was prolonged by cellulitis. The outcome of the event was unknown. The relatedness between the PNEUMOVAX 23 and the event was unknown. Additional information has been requested.
3 days of body pain; muscle aches all over body and face; muscle aches all over body and face; other vaccine same date; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; dose 1) via an unspecified route of administration on 22Jan2021 at 09:00 (at the age of 51-years-old) as a single dose in the left arm for COVID-19. The patient had no medical history. She was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not take any concomitant medications. The patient received another unspecified vaccine on 22Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient previously took penicillin from an unspecified date for an unspecified indication and experienced allergy. On 23Jan2021 at 06:00, the patient experienced 3 days of body pain and muscle aches all over body and face. The patient did not receive any treatment for the events. The patient was not hospitalized for the events. The outcome of 3 days of body pain and muscle aches all over body and face was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot number cannot be obtained.
this patient died at home; there are no medical records; pt did have a positive COVID test on 12/27/21; per death certificate, the causes of death were Respiratory Failure, COVID 19, Protein Calorie Malnutrition
Ketoacidosis (DKA), type 1 diabetes This all began in September 2004 Was admitted to the ER, then sent to ICU for an insulin drip and regulation of body chemistry. Could have resulted in death if it had gone on any longer. Treatment: gave patient blood glucose monitor, and taught how to test self and administer insulin shots.
Tingling.  Observed for 30 minutes due to history of mast cell activation syndrome.  Reported full body tingling after minutes.  At the 30 minute observation, noted that all the tingling had disappeared.
Pt vaccinated w/DTP/OPV developed a slight temp, put to bed, knot on his leg where shot was administered, Next day temp 104-105, stiff & his body was jumping, Head maybe growing too big, possible water on brain.
Left side of head/face numbness with continued left ear pain/discomfort.  No current treatment.  PCP following.
This spontaneous report as received from a pharmacist refers to a 66 year old female patient with rheumatoid arthritis (it was also reported that she had no relevant medical history or relevant concomitant medications). On 15-OCT-2017, the patient was intramuscularly vaccinated with 0.5 ml dose of PNEUMOVAX 23 for prevention of pneumonia, lot # M005286, that expired on 08-OCT-2017. Concomitant therapies included methotrexate (manufacturer unknown). As of 15-OCT-2017, it was unknown if she would receive PNEUMOVAX 23 again.
A few hours after the patient received Varicella injection the area became half dollar size and hot. She had red raised areas at the side of her face and on leg.
Severe low back pain. At site of pain, skin was red and hot to the touch. There were also several other "hot spots" along spine. Also general feelings of illness, pain at injection site.
called back to schedule her second appointment but is was past 42 days so they said she could not schedule; tested positive for Covid/Got COVID; tested positive for Covid/Got COVID; Tiredness; achiness; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 19Feb2021 13:00 (at the age of 68 years) (Batch/Lot Number: EN6200) as a single dose to prevent getting COVID (COVID-19 immunization). Ongoing medical history included high blood pressure (started about 10 years ago) and varicose vein (At least probably about 20 years). Family history includes both of her parents had heart problems, Mother had a stroke (she doesn't know when, she took medications for heart problems) and Father died of a heart attack. Concomitant medications included hydrochlorothiazide taken for hypertension. It was reported that the patient had the first dose on 19Feb2021 and was due to have second dose on 13Mar2021 and two days before that (11Mar2021) she ended up being sick having symptoms (cold) so she had to cancel the appointment and was tested for COVID. On 17Mar2021 the patient found out she got COVID. She called back to schedule her second appointment but is was past 42 days so they said she could not schedule. It was reported that she was not sure when she had COVID-19, it would have been in the evening when she started feeling like she had a cold. She's still having a little bit of tiredness since 11Mar2021 but no cough. Her tiredness is not as bad now. The patient also experienced achiness on an unspecified date in 2021. The patient received the following treatment for the events: Vitamin C, not sure if helped, Vitamin D, not sure if helped, and Advil, helped with achiness. The outcome of the event tiredness was not recovered, while unknown for the rest of the events.
Patient stated she was in bed for 2 days, had a headache and the injection site was itchy and red.
Heart palpitations and heart pain (like a tight feeling), took about a week to feel normal. Kept my heart rate down for a few weeks afterward, intentionally. Felt very unsafe.
Left arm began swelling and was becoming hot to the touch on the evening of 10/28/16. Pt applied ice. On 10/29/16, the swelling increased and blisters began to appear. Pt went to the ER was given antibiotics and sent home.  On 10/30/16, condition worsened with swelling from shoulder to the wrist and pt was unable to bend elbow and blisters worsening.  Pt went back to the ER, BP was 206/109 and her temperature was 103 degrees.  She was diagnosed with Cellulitis and placed on more antibiotics.  She was seen on 10/31/16 by her private physician who did an ultrasound on a hard knot that was present at the injection site, to r/o infection. By 11/1/16, the swelling was decreasing and the blisters were healing.
area of the injection red; area of the injection hard (the size of a softball); area of the injection tender to touch; itching at the area of the injection; minor soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (minor soreness at the injection site), VACCINATION SITE PRURITUS (itching at the area of the injection), VACCINATION SITE ERYTHEMA (area of the injection red), VACCINATION SITE INDURATION (area of the injection hard (the size of a softball)) and VACCINATION SITE PAIN (area of the injection tender to touch) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (minor soreness at the injection site). On 19-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the area of the injection). On 21-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (area of the injection red), VACCINATION SITE INDURATION (area of the injection hard (the size of a softball)) and VACCINATION SITE PAIN (area of the injection tender to touch). On 13-Feb-2021, VACCINATION SITE PAIN (minor soreness at the injection site) had resolved. On 22-Feb-2021, VACCINATION SITE PRURITUS (itching at the area of the injection) outcome was unknown. At the time of the report, VACCINATION SITE ERYTHEMA (area of the injection red), VACCINATION SITE INDURATION (area of the injection hard (the size of a softball)) and VACCINATION SITE PAIN (area of the injection tender to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Rt upper arm became red, swollen, hard, painful, itchy almost immed per mom.
This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer Sponsored Program. A male patient of an unspecified age received first dose of BNT162B2 (Lot number: EK5730) on 21Dec2020, second dose of BNT162B2 (Lot number: EL1284) on 11Jan2021, and both via an unspecified route of administration at single dose for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. The patient stating that he received his first dose of Covax on 21Dec2020 Lot#EK5730 and his second dose of Covax on 11Jan2021 Lot# EL1284, stating that after testing IGM and IGG he is negative for antibodies. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date in Jan2021 (Batch/Lot number was not reported) as dose 1, single, on an unspecified date in Feb2021 (Batch/Lot number was not reported) as dose 2, single, on an unspecified date in Oct2021 (Batch/Lot number was not reported) as dose 3 (booster), single, all via an unspecified route of administration for Covid-19 Immunization. Age at vaccination was unspecified. The patient medical history and concomitant medications were not reported. The patient travelled internationally in Jun2021 and tested negative 6 times and an antibody SARS-CoV-2 trimeric resulting in 225 AU/mL. He travelled internationally in Aug2021-Sep2021 and tested negative 5 times. In mid-Oct2021 he repeated the SARS-CoV-2 test resulting in 7 AU/mL. In Oct2021 (reported as a week later) he was infected, on the same day he received the booster. In Oct2021 (reported as a week later) he tested positive using Antigen and Rapid. Not good track record. The outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Could not get out of bed. Pains all-over, Joints, swollen upper arm of injection, dizzyness, fatigue, weakness - feeling like having the flu, numbness (even in face), stiffness all over. Feeling so bad, I had to call in sick at work.
Client vaccinated with Janssen vaccine for Covid in May 2021.  Not boosted.  Symptoms started 12/29/2021 - dizziness, headache.
Information has been received from a licensed practical nurse (L.P.N.) concerning an 8 year old female who was vaccinated with a first and second dose of VARIVAX (Oka/Merck) (lot # 639435/0789L for dose 1, 654280/1889U for dose 2) in July 2002 and on 24-JUL-2008, respectively.  It was reported that the patient was seen in physician's office on 05-JAN=2008 with a "full blown case of crusted lesions in 3 stages".  The lesions were on patient's face, legs and torso.  As of 06-JAN-2008, the patient was not recovered.  Follow-up information was received which reported that the black female patient who was vaccinated with a first and second dose of VARIVAX (Oka/Merck) (lot # 639435/0789L for dose 1, 654280/1889U for dose 2) SQ into the right arm and the left arm on 07-JAN-2002 and 14-JUL-2008, respectively.  It was report that the patient "break the VARICELLA" in office at 12:00, 05-JAN-2009, and experienced "papules, vesicles and crusted lesion 3 stages suffered over extremities, face and legs".  The patient has recovered within 2 weeks.  No further information is available.
The patient is 14 years old and Moderna vaccine was given by mistake.  No adverse event! The patient is doing fine so far.
This spontaneous report was received from a pharmacist and refers to a 67 year old female patient. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 30-DEC-2017, the patient was vaccinated with PNEUMOVAX 23, 0.5 ml dose, intramuscularly for prophylaxis (lot # N003993, expiration date 13-JAN-2018). Other suspect therapies included ADACEL (received on the same day). On 30-DEC-2017, right after the injection, the site was sore. On 31-DEC-2017 (reported as next day), when the patient woke up, the injection area was swollen and warm to touch. Patient reported that swelling went down her arm, close to her elbow (date unknown). Patient took TYLENOL to relieve symptoms. Patient reported that swelling and soreness were very bad for 3 days but within 5-6 days of receiving injection, most of symptoms were resolved. There was no laboratory diagnostic studies performed. The relatedness between the event and PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1801USA006659.
Had the second shot end of Feb.  Early March had routine checkup and doctor noticed my pulse was only 38bpm.  He ordered a monitor device attached to my chest for two weeks.  The device showed heartbeats of over 3 seconds and sometimes over 4 seconds.  I was sent to a cardiologist who ordered a pacemaker.  During EKG's the cardiologist found some atrial fibrilation.
Presented with SOB, low grade temp; + Covid in ED; admitted with PE, Covid & dyspnea; no hypoxemia; tx for PE; no tx for COVID
High fever of 102.7, muscle/body aches, dizziness, chills, headache
Pt noticed some swelling and pain in left posterior arm that next morning which continued to swell the day after that on 02/07/2016. Pt was seen at little clinic that Monday afternoon for pain and swelling; had heat and tenderness to touch. Pt was diagnosed with cellulitis and placed on amoxicillin and declined further medical treatment after this.
presents with a potential reaction to the COVID19 vaccine. I was summoned to the patient's vehicle. She was responsive, by pale and diaphoretic slumped in the back seat. Given the nature of the vehicle, her position could not be changed. EMS was summoned so the patient could be repositioned on a gurney properly with legs elevated. The patient was responsive and relayed a history of POTS. Documentation was reviewed in detail, she does use a Clonidine patch. VS were WNL via EMS. The patient had not had anything to eat or drink today. Given this, 1L of IV fluids was started via EMS.  This was a vasovagal episode with syncope in the setting of known POTS currently under treatment. With close monitoring, hydration, and repositioning, the patient returned to baseline and was returned home with her parents.