chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chest pain; Racing heart beats; He had difficulty breathing; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization. The following information was reported: CHEST PAIN (non-serious), outcome "recovered"; HEART RATE INCREASED (non-serious), outcome "recovered", described as "Racing heart beats"; DYSPNOEA (non-serious), outcome "recovered", described as "He had difficulty breathing". The events "chest pain", "racing heart beats" and "he had difficulty breathing" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of chest pain, heart rate increased, dyspnoea.  Additional Information: Individual was advised by medical professional to not receive any more mRNA vaccines including the new COVID vaccine. About a week after receiving the second dose of the initial COVID vaccine, individual experienced chest pain and racing heart beats. As an athlete, the individual was unable to participate in a marathon because his chest would burn and he had difficulty breathing. When he returned to his racing, he would only run for a brief time until his heart rate got too fast. It took almost a full year for all the symptoms to resolve. The patient did not test positive after or before vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe shaking on entire body; Scared to death; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Severe shaking on entire body) and FEAR OF DEATH (Scared to death) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Neck injury NOS (damage on his neck). Concomitant products included ALBUTEROL [SALBUTAMOL] for COPD, VITAMINS NOS, CALCIUM and MAGNESIUM for an unknown indication.   On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced TREMOR (Severe shaking on entire body) and FEAR OF DEATH (Scared to death). On 08-Mar-2021, TREMOR (Severe shaking on entire body) and FEAR OF DEATH (Scared to death) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was told by his physician that he would need surgery for his damage on neck.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: follow up received no significant information
The patient received the Pfizer COVID-19 vaccine on 2/10/21 and 3/3/21, so was fully vaccinated when he tested positive for COVID-19 on 8/13/21.
Developed palpitations and tachycardia with sustained HR in low 100?s (baseline is 55). Febrile to 103, chills, rigors, nausea/vomiting.
Client came into our clinic requesting her first dose of Moderna.  She denied any other covid vaccines on her consent fprm and reported this dose as her "first Moderna".  She was given a dose of Moderna.  When entering in client information, initially nothing was pulled forward from the registry when creating a patient profile.  When entering in the dosage given,  a 3 dose series of Pfizer pulled into our system.   Pfizer dosages were given 1/23/21, 2/17/21 and 8/26/21.  Client reported that her physician instructed her to come in to the clinic to get a series of Moderna vaccines because she "didn't have antibodies" after receiving the Pfizer vaccine.   Client was monitored for 15 minutes after vaccine administration.  There was no adverse events at that time.
Pt had malaise and anorexia.  The next morning she had fever/chills, malaise, anorexia, mild nausea -- and this persisted 2 days after vaccination with 1 day of local redness, swelling, warmth, induration and pain of the injection site (left deltoid).  Seen in ED where she was found to have leukocytosis also.  Treated with vancomycin/unasyn for presumed cellulitis and over the next day her fever and chills and leukocytosis improved - as did her malaise.  But the redness/swelling persisted and the redness of her arm got worse.  Treated with vancomycin but feel that her reaction may have been a profound immune response to the vaccine.  Blood cultures negative.  skin intact.  12/01/09 and 12/29/09 DC summary for DOS 10/25/09-10/28/09 Final DX: cellulitis of upper arm, reaction to vaccine, hyponatremia, SIADH, leukocytosis and anemia. Pt c/o malaise, redness, tenderness, swelling at site of injection, anorexia/nausea and fever/chills. Upon physical examination, Pt had 12 cm erythematous indurated area of L upper arm, warm to touch. Pt was taking chemotherapy at the time of this event. WBC increased with a left shift.  TX:Vancomycin and Unasyn treatments started. Fever resolved during hospitalization.  Pt recommended to not take Pneumovax vaccine in the future due to potential allergic reaction. Pt discharged home in stable condition.
Fever of 103.2 degrees 2 hours after vaccines. Rash developed 2 days later. Parents took child to ER and md diagnosed as Chicken Pox.
Red, warm, swollen (8cm x 6cm) - mother gave ibuprofen - symptoms started Wednesday. Mother notified office Thursday. Pt was seen in office Thursday. Mother to continue to monitor. 8/1/14 - mother said red area gone. (No fever per mom).
Pt with no PMH. Was administered IM vaccine at approximately 08:45. Within 5 minutes endorsed feeling dizzy, appeared pale and slightly diaphoretic. Pt had witnessed syncopal episode at approximately 08:50. Pt seated with nurse and site employees at side to assist in ensuring safety. No injury occurred. Syncopal episode duration approximately 30 seconds. Pt became unresponsive, bradycardic and slightly hypotensive. Vitals: 110/55, 50, 13, 98%. EMS activated, PD called, and Capt called to be made aware of situation. Pt given Gatorade 150 ml and endorsed prior syncopal episodes with vaccines and blood draws. 8:53- Pt able to sit upright independently, drink fluids w/ no complication, AAO x4. Pt vital signs stabilized within 5 minutes with no other interventions other than PO fluids. PD arrived onsite 8:56, asked pt if he required medical assistance, pt declined. PD officer given report by lead RN. RA 51 arrived 8:58, report given by lead RN, pt evaluated, performed EKG finding NSR, and fingerstick glucose result of 163. 09:00- pt reports dizziness resolved, and declined transport to hospital by PD and signed AMA. 09:45 pt remained continuously monitored by site RNs, along with PD assessment. Pt exited site ambulatory with no further incidents accompanied by wife.
Patient describes red, with a little swelling, itchy, rash like .  Patient will take benadryl and contact his doctor
aching arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "aching arms".  Additional information: Product strength is 15 ug. The patient is asking if anyone else has reported aching arms months after receiving the Pfizer COVID-19 bivalent vaccine and what to do to treat it and how long does it usually last.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Client received a flu shot on 10-08-03 at a Clinic held at a local grocery store.  No previous health complants before shot.  Approx. 2 days after shot complaint of Left side, posterior neck pain, along with muscle soreness to both arms, deltoid area. Complained of pain in both knee joints also. No fever noted, No swelling or reddness noted. Descrbes pain as "someone sticking a knife into arms, Pain is intense."  Rates pain as 10 on a 1-10 scale. On 10-23-03 blood tests were done to see if meds client was taking was causing pts problems.  On 10-28-03 visited doctor.  Reports blood tests were normal. Started pt on Vioxx,and other pain med Lortab?  Vioxx did not help so revisited doctor on 11-25-03, started on Prednisone 20 mg.  Med helped.  Referred pt to Rheumatoidologist on 12-08-03.  Prednisone was reduced, to 2.5 mg. with terrible pain returning.  Visited doctor again,2-12-04 increased Prednisome to 5mg and added Methatrextate.  Rates pain as 8 on 1-10 scale today 3-03-04. Scheduled for additional follow up appointments in March 04.
13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is 12th of 13 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), 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. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week on an unspecified date. The outcome of the events 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-2021018407 same reporter, similar suspect drug and event; different patient
pt recv vax 3JUN96 & 5JUN96 pt devel a red swollen face w/both eyes almost closed & a fever of 99.2;
This spontaneous report as received from a registered nurse refers to multiple, unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL 9 via unreported route (batch # L026602, exp. 19-OCT-2017; L045711, exp. 08-MAY-2017; K006124, exp. 02-FEB-2017). Concomitant medication was not mentioned. The vaccines underwent a temperature excursion by being stored at 0.9 degree centigrade for a time frame of 11 hours 35 minutes on 18-MAR-2016. The call was a result of "data logger". There was no previous temperature excursion mentioned. No adverse effects were reported. Product quality complaint was not filed. Additional information has been requested. This is one of the four reports received from the same reporter.
3/29/03 Temp 100.4 4/1 - 4/3/03 Low grade fever, not measured by PT. 4/2/03 2-3 p.m. left midsternal interecstal pain which persisted. 4/3/03 12:30 p.m. visit to MD with increased intercestal pain mid sternal and shortness of breath 2ndary to pain and expansion of chest wall breathing. Had 2 normal EKGs, NG?, RUBS, no murmur. Dx Intercostalcondritis - 3 cd, 4 ch, 3 ca. Left of sternum. Rx Indocin, Percoset, Pervacid. Rest at home 1 wk of 4/3/03 improved but still some discomfort with deep arthralgia.
Patient reported feeling 'weird' after his 15 minute observation period. About 25 minutes he ended up losing consciousness. He returned consciousness 1 minute later and was able to recite his name and sit up and talk. He ended up leaving with his wife after the paramedics came and cleared him.
Moderna vaccine booster was administered on 11/5/2021 with an expiration date of 10/11/2021. Inquiry has been submitted to Moderna requesting validation of vaccine potency.  A response from Moderna is expected to be received between 8-10 business days.  Expiration date is currently not printed on the vaccine vial or carton and vaccine expiration date listed in VAOS is 12/31/2069.  To find the expiration date, ?look up expiration date? tool is to be used from Vial Expiration Date Lookup | Moderna COVID-19 Vaccine (EUA). Patient contacted on 12/4/2021 and no adverse effects reported.
Extreme fatigue, headache, sore throat, and high fever. The high fever ran for a few days. I had no appetite. I slept a lot.
Fluarix quad 19/20 vaccine was administered at around 5:50pm and around 5:55 or 6pm the patient almost fainted onto the parents. He was brought back to pharmacy area and sat with eyes closed but was responsive. He was sweaty and then became nauseous and vomited. He said he felt better after vomiting. This was likely vasovagal adverse reaction to the vaccine. Mom said he was fine 1 hr later.
p/vax pt noted redness, swelling & itching around inj site;also c/o nausea, h/a & feeling feverish & took 2 ASA for discomfort;then became diaphoretic, dizzy, tingling of both arms, shaky & weak;taken to hosp ER given DPH & ATB;disch 10/8
Muscle Pain; Swelling; Rash/spreading to arm; rash around injection site; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 3rd June 2019, 5 hrs after receiving Shingrix, the patient experienced muscle pain, swelling, rash and injection site rash. On an unknown date, the outcome of the muscle pain, swelling, rash and injection site rash were unknown.   It was unknown if the reporter considered the muscle pain, swelling, rash and injection site rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. About 5 to 6 hours post vaccination she experienced muscle pain, swelling, and a rash.  The rash started out as 2 inches all around the injection site, expanded to 4 to 5 inches and  spreading to the patient's arm. the patient had recovered from the swelling, and the muscle pain had dropped from 7 to 3 on a scale of 1 to 10. The patient had not went urgent care.  The reporter did not consent to follow up.
Information has been received from a nurse, referring to an unspecified number of patients (ages and genders not reported). The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates in June 2017 (reported as "on 13-JUN-2017 and 14-JUN-2017"), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number M046140 with expiration date on 27-SEP-2019 (strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported and no additional information was provided. The vaccines had a temperature excursion of 0 Celsius (C) to 1 C during 30 minutes, it was also confirmed that the vaccines did not have previous temperature excursions and a digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA007425:
Female patient oriented in time and place comes to the area of vaccination, looks anxious and shaky, we talk to her to calm her down and proceed to get her vaccinated. Continues to the area of observation and reports to Paramedic feeling chest tightness and patient indicates not having hypertension but at work her pressure goes up. Patient indicates that today she went to the cardiologist and felt good but anxious. Her pressure was taken 160/100 and water was given to her, after a few minutes she indicates feeling better. Her pressure in taken again 130/70 patient indicates feeling good and walks to her mother.
Onset with redness around injection site on left thigh, warm to touch night of 4/14/04. 5.5x4 inch erythema blanching to left thigh, slight tenderness to palpation. Benadryl 1-2 times a day. Ibuprofen prn discomfort.
Initial unsolicited report received from healthcare professional via other company (Pfizer) (manufacturer control number: 2017250412) on 05-Jul-2017. This case involves a male patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Influenza Virus Vaccine) (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date in Oct 2016. The patient's medical history and concomitant medications were not reported.  On an unspecified date, following the vaccination, the patient experienced GBS (Guillain Barre Syndrome). Lab data and corrective treatment were not reported. Outcome of event was not reported.  Upon internal review, the company decided to consider the event serious because of important medical event developed gbs (Guillain Barre Syndrome). List of documents held by sender: none.; Sender's Comments: The patient experienced guillain barre syndrome post vaccination with influenza vaccine (MFR UNK). Time to onset was not reported. No information regarding patients tolerance to past vaccinations or concurrent medical conditions was reported. Investigations ruling out alternate etiologies should be performed and information regarding product name dose and manufaturer should be obtained. Based on available information the role of the vaccine can not be assessed.
sinus problems; vaginal itching; shingles; shingles to the left buttock; shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date before May 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) by a healthcare provider in a pharmacy, for the prevention of shingles. Shortly thereafter, the patient suffered a severe rash. She began having outbreaks as frequently as twice per month. On 07-MAY-2015, the pt went to see a doctor and stated she thought she might have had the beginning of shingles on her left buttock and stated she had had the vaccine. She was given acyclovir (ZOVIRAX) for 7 days. On 30-JUN-2016, the patient presented to the doctor for shingles to the left buttock and was again given acyclovir (ZOVIRAX) for 7 days. On 09-JAN-2018, she presented to the doctor for sinus problems, shingles and vaginal itching. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the patient suffered painful and debilitating symptoms, which had resulted in physical and mental and emotional pain an distress not present to using zoster vaccine live (ZOSTAVAX). As a result of manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccination, the patient had suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient had incurred and would incur medical expenses and other economic harm as a direct result of the usage of zoster vaccine live (ZOSTAVAX). The relatedness between the events and zoster vaccine live (ZOSTAVAX) was related.  Upon internal review, the events of shingle, sinus problems and vaginal itching were considered to be disabling.
During vaccine monitoring, patient's mother concerned that her daughter does not feel well. Patient was feeling whoosy and did not have anything to eat that morning. Patient spit in a plastic bag and was given alcohol swabs to smell. Requested water but was told to have nothing by mouth at this time. Patient monitored for an additional 30 minutes and was better.
severe arm pain so much that I could not lift my arm at all for 2 days, couldn't sleep, put on a coat, reach for seat belt.  Arm also had no strength.  Finally took ibuprophen 600 and 800 mg doses to reduce swelling.   3 days out now I can lift arm halfway.  just thought I should report.  I hear dose 32 has more side effects but I will take it
having migraine every couple of days; Inflammation in knew and elbows; Gastro (stomach) issues; Extremely Gassy; Wet stool; Chronic fatigue; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (having migraine every couple of days), JOINT SWELLING (Inflammation in knew and elbows), ABDOMINAL PAIN UPPER (Gastro (stomach) issues), FLATULENCE (Extremely Gassy) and DIARRHOEA (Wet stool) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced MIGRAINE (having migraine every couple of days), JOINT SWELLING (Inflammation in knew and elbows), ABDOMINAL PAIN UPPER (Gastro (stomach) issues), FLATULENCE (Extremely Gassy), DIARRHOEA (Wet stool), FATIGUE (Chronic fatigue) and NAUSEA (Nauseous). At the time of the report, MIGRAINE (having migraine every couple of days), JOINT SWELLING (Inflammation in knew and elbows), ABDOMINAL PAIN UPPER (Gastro (stomach) issues), FLATULENCE (Extremely Gassy), DIARRHOEA (Wet stool), FATIGUE (Chronic fatigue) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  Treatment details included Tylenol(paracetamol), Ibuprofen, Advil and Motrin.
Developed hives on her skin; big red bumps on her skin; big red bumps on her skin; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Developed hives on her skin), SKIN SWELLING (big red bumps on her skin) and ERYTHEMA (big red bumps on her skin) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Developed hives on her skin), SKIN SWELLING (big red bumps on her skin) and ERYTHEMA (big red bumps on her skin). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) at an unspecified dose and frequency. At the time of the report, URTICARIA (Developed hives on her skin), SKIN SWELLING (big red bumps on her skin) and ERYTHEMA (big red bumps on her skin) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication not provided.  Treatment information not provided.
Slight sharp burning pain "behind" left eye begin a few hours after I had shot. That pain was intermittent for a few hours and dissipated by early evening  of the day of the shot.  My left lip and left side of throat had minor feeling of tingly burn when I was driving home 30 minutes after I had the shot. Stiff muscles on left side of neck. Intermittent mild muscle pinching along left side of body but went away by Friday night.