chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Presented with an inflammation on the back; Had swollen on the back on right side and now, she has swollen on the left side; This is a spontaneous report from a contactable other hcp. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6206) via an unspecified route of administration, administered in Arm Right on 04Apr2021 as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications was reported. On an unspecified date the patient experienced presented with an inflammation on the back, had swollen on the back on right side and now, she has swollen on the left side. Additional Context: Reporter (Nurse) stated, I am calling on behalf of my aunt who received a Pfizer vaccine on 04Apr and she got the second dose on 25Apr. After the first dose, she puts into (voice not clear), she presented with an inflammation on the back on the same side as the dose (not clear) and with the second dose she presented the same symptoms on the left arm and inflammation on the back on the same side. Is that normal. No treatment was received for the events. The outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Normal pulse ox. Local reaction (site) - hives, redness. BENADRYL 5ml given as ordered by M.D. ok to leave after 30 minute observation.
INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTRATION; BRAIN FOG; STOMACHACHE; NOXIOUS BURPS; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included bnt 162 for prophylactic vaccination. On APR-2021, the subject experienced brain fog. On APR-2021, the subject experienced stomachache. On APR-2021, the subject experienced noxious burps. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fatigue. On 22-JUN-2021, the subject experienced inappropriate schedule of vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from brain fog, stomachache, noxious burps, fever, headache, and fatigue, and the outcome of inappropriate schedule of vaccine administration was not reported. This report was non-serious. This case, from the same reporter is linked to 20210661890.
has an appointment tomorrow for the 2nd dose but she tested positive on  08Feb; has an appointment tomorrow for the 2nd dose but she tested positive on  08Feb; This is a spontaneous report from Pfizer-sponsored program received from a contactable consumer reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient had an appointment tomorrow (17Feb2021) for the 2nd dose but she tested positive on 08Feb2021. The outcome of the events was unknown. The information on the lot/batch number had been requested.
In addiction to developing left injection pain an hour after injection on Thursday, Saturday developed left ear pain, then Sunday developed left jaw pain, Monday developed left facial rash, Tuesday developed headache, pain numbness/tingling  to left side of face and worsening rash. Wednesday worsening symptoms diagnosed by MD with shingles.
Headache, Myalgia, Fever, CHILLS, FATIGUE Narrative:  Other Relevant History:
fever; pain going through arms, then legs, then left side near arm; swelling in extremities, especially fingers; tiredness; some pain in calves; This is a spontaneous report from a contactable consumer (Patient). A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18Jun2021 12:00 PM (Lot unknown: True, Lot unknown reason: Other, Lot unknown reason other: EW0168) (at the age of 59-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included seasonal allergies, headache, (nothing but seasonal allergies and headaches) and Known allergies: penicillin. If covid prior vaccination: No, If covid tested post vaccination: No. Facility type vaccine: Other. Concomitant medication(s) included acetylsalicylic acid (ASPRIN) taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; pseudoephedrine taken for an unspecified indication, start and stop date were not reported; spironolactone taken for an unspecified indication, start and stop date were not reported.  If other vaccine in four weeks: No. The patient previously took povidone-iodine [BETADINE] and experienced drug allergies (Known allergies: penicillin, betadine). The patient experienced pain going through arms, then legs, then left side near arm (non-serious) on 18Jun2021 14:30 PM, swelling in extremities, especially fingers (non-serious) on 18Jun2021 14:30 PM, fever (non-serious) on 20Jun2021, tiredness (non-serious) on Jun2021, some pain in calves (non-serious) on Jun2021. For events, pain going through arms, then legs, then left side near arm, outcome was recovered with sequelae in unspecified date in Jun2021, swelling in extremities, especially fingers, outcome was recovered with sequelae in unspecified date in Jun2021, fever, outcome was recovered with sequelae in unspecified date in Jun2021, tiredness (non-serious), outcome was not recovered, some pain in calves (non-serious), outcome was not recovered.
One blister type lesion at injection site of varicella Per follow up: 3/10/06 pt received vaccine at Clinic. We don't have the information requested.
Initial report received on 04 December 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 13-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL on 01 December 2011, 02 February 2012, and 03 April 2012 (lot numbers, routes and sites of administration not reported). The subject developed a cough on 07 November 2012, approximately 7 months after the last dose, and a paroxysmal cough without a whoop on 08 November 2012. The subject also developed posttusive vomiting and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 09 November 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 09 November 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 28 November 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 26-FEB-2019, the patient was vaccinated with improperly stored dose of VARIVAX injection, lot # R020652, expiry date 18-JUL-2020 (strength, exact dose, route and site of administration were not reported) for prophylaxis. The suspected vaccine was reconstituted with sterile diluent. The suspected vaccine was stored in temperature from -9 degrees Celsius (C) to 8 C (-9.1 C) for 1 hour and 13 minutes. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1903USA000472:
Itchy throat making it more difficult to swallow. Nausea. Given Benadryl 50mg orally by NP. Vitals checked and monitored for an additional hour.
Report A0303842A describes possible mercury poisoning in a 59 year old female who received hep B vaccine recombinant after sustaining a needle stick injury. This report was received from the vaccinee, who is a nurse and has not been verified by a physician. The vaccinee reported that she had no allergies or medical history. However, she also reported that she took conjugated estrogens (Premarin), Prozac and baby aspirin. The vaccinee reported that she received the first and second doses of Engerix B on 09/08/1998 and 10/08/1998, respectively. She reported that "within one to two weeks" of receiving the second injection of Engerix B, three-fourths of her hair fell out and was "coming off from the follicle." She also reported that her hair became limp. She stated that she also experienced "occasional "earaches, "occasional" sinus infectious, anemia (manifested by decreased hemoglobin concentration, decreased hematocrit, and decreased total protein concentration), polyarthritis, muscle pain, "thumb not in joint," and "beginning in late May 2002 or early June 2002, her "tongue has sores and is very red." She started that she "thinks" that she has "mercury poisoning" because she received thimerosal in the Engerix B injections in 1998. She also stated that she experienced dryness of "all mucous membranes" and that she "now has" Sjogren's syndrome. She considered the "mercury poisoning" and Sjogren's syndrome to be possibly related to Engerix B administration. The most recent info received on 06/19/02, indicated that all the reported events were ongoing. This report of "mercury poisoning" is considered medically serious.
Vaccine was diluted with sterile water instead of the recommended normal saline. No adverse effects reported.
Pt's guardian came in and reported that patient had six Grand Mal seizures. Pt has a history of seizures, but has not had one in many months. Pt's guardian reports she is not sure if it is related to Immies, but wanted us to know. Pt has received care at Local ER following event.
Their probably hurt the arm when lifting boxes since they had to move twice and move some storage units as well; Having trouble with their elbows; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Their probably hurt the arm when lifting boxes since they had to move twice and move some storage units as well) and ARTHRALGIA (Having trouble with their elbows) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Their probably hurt the arm when lifting boxes since they had to move twice and move some storage units as well) and ARTHRALGIA (Having trouble with their elbows). The patient was treated with PREDNISONE for Adverse event, at a dose of 2 weeks. At the time of the report, PAIN IN EXTREMITY (Their probably hurt the arm when lifting boxes since they had to move twice and move some storage units as well) and ARTHRALGIA (Having trouble with their elbows) outcome was unknown.            No Concomitant medication was reported.     Patient reported that they recall their HCP saying had some immunosuppressive effects so they inquire when it would be ok to take the booster.
Toghtness in chest, localized rash on right wrist, trouble swallowing, sore throat all within 20 minutes of injection. Took inhaler and felt fine after 20 minutes.
Headache, Arthralgia, NauseaVomiting, FATIGUE, CHILLS, PAIN/SWELLING INJ SITE Narrative:   Other Relevant History:
A report has been received from regulatory authority via pharmacist concerning a 10 year old, Female subject, Height: 48.0 Inches; Weight: 55.0 Pounds, who had been receiving FLUMIST (intranasal), 0.1 mL, 2 every 1 Day(s). FLUMIST started on an unknown date. The patient experienced cough, decreased appetite, pain in extremity, pyrexia, lethargy, asthenia and rhinorrhea. The outcome of the event of cough, decreased appetite, pain in extremity, pyrexia, lethargy, asthenia and rhinorrhea is unknown. The report was considered to be non-serious.
Symptoms of stroke (facial paralysis and slurred speech) developed next day. Admitted to hospital; symptoms cleared in 24 hours. Diagnosis: TIA. Medical records state 7th nerve palsy. msv
Muscle spasms in neck, pain in quadriceps, pain in back, left arm felt heavy, headaches, hypertension, joint pain; numbness in fingers & ankles.
Nausea, emesis, facial flushing, HA. Cleared by EMS
On are around March 10 the right side of my tongue developed white sores.  I went to my dentist and he recommended an Oral Surgeon.  I saw Dr and he recommended a biopsy.  I was leaving town on an RV trip in 2 days so I said I would wait.  During my trip the sores became worse so I went to an Oral Surgeon in another city who prescribed a Prednisone mouthwash for the three weeks I was there.  This did nothing to change the sores.  When I returned  in June I had a biopsy at Dr office on June 21.
This spontaneous report as received from a registered nurse refers to a 14 month old patient of unknown gender. No concurrent conditions or medical history were provided. Nurse reported that on 29-AUG-2014 (during an appointment), a patient's mother incorrectly reported to the office that the patient had never received any doses of MMR II and (Oka/Merck) VARIVAX in the past. The patient was then vaccinated with doses of MMR II and (Oka/Merck) VARIVAX injections (dose, route of administration, indication, lot# and expiry date unspecified for both) during that appointment (on 29-AUG-2014). Later it was discovered that the patient had already received dose 1 of MMR II and (Oka/Merck) VARIVAX from a different provider's office (unspecified health department) on 12-JUN-2014. No concomitant medications were reported. No symptoms were reported. Additional information has been requested.
Crying for 3 hours. 10/17/2002 cried all afternoon/evening
I have been feeling horrible for about a month. Made a doctor's appointment only for them to tell me to get another vivid test. However I recently found out that I am pregnant. I have been on birth control for over 2yrs .  I was on the Depo shot and I am now pregnant.
After receiving immunizations at office visit, while ambulating in hall reported dizziness, then had a brief loss of consciousness and was lowered to the floor by mom.  Smelling salts used & he regained consciousness.  BP 106/70.
I had no symptoms up until May 3rd. I had high blood pressure - it was through the roof. - It was 193/101. I was experiencing dizziness and wobbly - not sure on my feet. ER. Changed dosage to  -  higher dosage -  Lisinopril and Amlodipine. Primary care doctor decided to give me Prednisone - I did the series of it and I no longer take it. Blood pressure is still high  and racing with the heart issues and working with the doctor to still get it under control and taking the meds. They did issue me Meclizine - in case I have a vertigo feeling.  May 26th - I told her I am not going to use her services anymore and so I'm seeing Dr. now. Remicade infusion every 8 weeks. I still go to work right now.
Pt developed burning down to fingers from site of injection and a large knot at injection site. She developed head shaking, severe joint pain, severe scarring rash, angina, palpitations, gout, arthritis, inability to read and retain information, diminished cognition, and chronic fatigue. There are more adverse events but due to space limitations they are not listed.
received Paxlovid as the treatment of COVID-19; received Paxlovid as the treatment of COVID-19; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 79-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Batch/Lot number: unknown), on 09Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 08May2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history included: "Parkinson's" (unspecified if ongoing); "Colon Cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Aug2022, outcome "unknown" and all described as "received Paxlovid as the treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Aug2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201057808 same reporter/patient/drug, different dose/event;
Pt received  vaccine at 1246, experienced tingling of tongue, lips, and eyelids and a sensation of throat tightening at 1257. patient self administered zyrtec 10mg  at 1258.  At 1345  patient was given 50 mg of benadryl.  VSS stable. symptoms improved.
Initial report received from a healthcare professional on 05 March 2014. Two patient, who demographics were unknown, had received an intramuscular first dose of ADACEL, (batch number U4825AA, site of vaccination unknown) on 03 March 2014. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. On an unspecified date, the patients experienced severe pain at injection site with swelling (1/2 dollar red raised at injection sites). Corrective treatment and laboratory details were not reported. At the time of this report the patient had not recovered. Document held by sender: none.
he had missed his second dose of GARDASIL 9 in a 3 dose series.; This spontaneous report was received from a the patient regarding himself, a male of unspecified age and race. His medical history , historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with the first dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) in a three dose series. On 07-MAY-2023, the patient missed his second dose of this suspect vaccine in a 3 dose series (Vaccine dose omission). No further information or adverse events were provided.
Client reports that she had symptoms similar to a heart attack the evening of her first shot, she was not able to provide more detail on specific symptoms.   The ER physician did not find any cardiac anomalies.
This spontaneous report as received from a pharmacist refers to a 87 year old patient of unknown gender. On 23-APR-2015 the patient was inadvertently vaccinated with PNEUMOVAX23 (lot # K004281, 0.5 ml, once, intramuscularly) that was expired 22-MAR-2015. No adverse effects reported. Additional information has been requested.
Pt recvd vax & 23MAR93 exp tightening of the throat (slow onset), & laryngospasm (gradual onset, 3:00 - 5:00 P.M.);
The mother reports the entire right thigh was hard, hot, very red and swollen. The patient also has some diarrhea.
Localized redness, tenderness to touch, arm swelling, hot to touch; Treatment Septra DS 1 tab PO BID x 10d
This spontaneous report as received from an unspecified reporter, as part of a marketing research program, refers to a 51 year old female patient who enrolled in a marker research program entitled "HCC adult vaccine location journey", information regarding relevant medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX23 (one dose in the arm, route and lot # not reported). Information regarding concomitant medications was not reported. Approximately on an unknown date in 2014, the patient had lump on arm at the injection site. It was reported that the lump "cleared" after 3 days at most and the patient recovered from the event on an unknown date in September 2015. The reporter considered the event to be related to PNEUMOVAX23. Additional information is not expected because the reporter refused to provide contact information.
Diarrhea, vomitting, and what appeared to be blood began 3 days post-vaccination and subsided 10 days post-vaccination. It was clear blood was in pt. stool 1/2/2021 and 1/12/2021 (unclear prior to these dates). No symptoms continued after 1/12/2021.
Pain at injection site (Left Arm) and shoulder area - similar feeling as of the day of the shots
Information has been received from a medical assistant concerning a 23 year old female with no pertinent medical history or drug reaction/allergies, who on 8/31/06 was vaccinated IM with a pre filled syringe HPV rL1 6 11 16 18 VLP vaccine yeast (lot 654540/0800F). There was no concomitant therapy. The medical assistant reported that the spring action activated so forceful the needle and spring popped out of the clients left arm and scratched her. It was reported that all the vaccine was administered and that the pts left arm was washed with soap and water. She also reported that the pt did not bleed. No further details were provided. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 10/6/2006.  Initial and follow-up information has been received from a medical assistant concerning a 23 year old white female with no partinent medical history of drug reactions/allergies, who on 31-AUG-2006 at 2:00 PM was vaccinated intramuscularly in the left deltoid with the first dose of a pre-filled syringe of GARDASIL (Lot # 654540/0800F).  There was no concomitant therapy and no illnesses at time of vaccination.  The medical assistant reported that "when the needle safety device was activated, it came down so forceful that the needle and syringe popped out of the client's left arm, struck the patient, and scratched her."  The reporter stated that the "syringe deployed as it should have, but was unexpected" by the health care provider.  It was reported that the plunger was released before removing the needle from the arm of the patient.  The reporter stated that there was no damage noted to the syringe.  It was reported that all of the vaccine was administered and that the patient's left arm was washed with soap and water and a bandaid was placed over the puncture site and scratch.  The reporter also stated that the patient did not bleed and taht there was no adverse reaction to the patient.  The patient subsequently recovered.  No further information is expected.
PT. had Rabies Immune Globulin and first Rabavert 8/27/2019.   Approx. 12 hours after immunization she developed DKA.  Was admitted to Hospital ICU.  She received Day 3 Rabavert  8/30/2019.  She developed elevated glucose levels, up to 300, but was able to manage at home with insulin boluses. Received Day 7 Rabavert 9/3/2019.  She reports she developed elevated glucose, but only to 230.  Managed with insulin boluses at home. Normally does not have glucose spikes.  Pt. reports she is a very well controlled diabetic.  No other instances of DKA outside of the Rabies vaccines.