chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red itchy patch approximately 2 1/2  inches in diameter at or near the injection site noticed 6-7 days afterwards and is still present this date.  This is the same area in which I had a very warm sensation 4-6 hours after the injection.
The day after the shot:  Fatigue, shortness of breath, pain at injection site, dizziness, foggy brain.
4-mo-old w/cortical blindness & developmental problems since birth was vax'd w/MMR; following the vax, the child experienced additional developmental delays;
Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache) 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.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced HEADACHE (Severe headache). At the time of the report, HEADACHE (Severe headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No treatment information was provided. No relevant concomitant medications reported.
After a couple of years of not getting a period (now age 53), two days after receiving the Pfizer COVID-19 vaccine I got a heavy menstrual flow.  Still experiencing the menstruation right now.  Will be seeing my doctor today for guidance as I'm scheduled to get the second vaccine soon.
had been slowly gaining water weight and all of a sudden in Aug it began to accelerated to the point where he couldn''t breath very well and his oxygen dropped; all of a sudden he gained 5 pounds that proved to be water gain; all of a sudden he gained 5 pounds that proved to be water gain; inability to take full breaths; getting tired easily; This is a spontaneous report from a contactable consumer. A 55-year-old male patient received bnt162b2 (Lot Number: ER8734; Expiration Date: 31Jul2021), dose 2 via an unspecified route of administration, administered in arm left on 03Apr2021 10:00 (at the age of 55-year-old) as single dose for covid-19 immunisation. Medical history included asthma (in past and lungs not so great). The patient's concomitant medications were not reported. The patient previously received first dose of BNT162b2 (Lot number: EN6208, Expiry Date: 30Jun2021) in left upper arm on 13Mar2021 for Covid-19 immunization and no adverse effect. The patient wanted to report back about the virus check he had a health situation that arose that may have traced back to the second Pfizer Covid vaccine. He ended up in the emergency room and had extensive follow up visits and nothing was apparently resolved. The received the second vaccine on 03Apr2021. It took a while for things to happen and it wasn't obvious at first. He had inability to take full breaths and was getting tired easily. That started about a month or so after the second vaccine, after May. It got slowly worse over time until it got to Aug2021 and then all of a sudden he gained 5 pounds that proved to be water gain. He had been slowly gaining water weight and all of a sudden in Aug it began to accelerate to the point where he couldn't breathe very well and his oxygen dropped. The extensive follow up visits started also 09Aug2021 and he is currently being treated with diuretics. They started him on one dose and then another one. Clarifies he is being treated with Furosemide (brand Lasix) 20mg 1 tablet by mouth daily, but originally was on 40mg. Unable to provide the NDC, Lot, or expiry for either dose from orange pharmacy bottle. Family medical history relevant to the events was none. No further details provided. No other vaccines received the same day and no problems with vaccines in the past. States his last appointment he had was on 09Sep2021. No further details provided. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Pfizer monovalent was given instead of the bivalent due to look alike vials.
This pt was inadvertently given the adult strength booster instead of the pediatric dose booster.
She had a really bad headache, so I gave her 1 Ibuprofen and then she started complaining that she felt like pins and needles were sticking her all over her  body. I was told it was not vaccine related.
I received my second dose an hour ago.  Now I'm coughing; I received my second dose an hour ago.  Now fluttery feeling in my chest; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (I received my second dose an hour ago.  Now I'm coughing) and CHEST DISCOMFORT (I received my second dose an hour ago.  Now fluttery feeling in my chest) 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.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (I received my second dose an hour ago.  Now I'm coughing) and CHEST DISCOMFORT (I received my second dose an hour ago.  Now fluttery feeling in my chest). At the time of the report, COUGH (I received my second dose an hour ago.  Now I'm coughing) and CHEST DISCOMFORT (I received my second dose an hour ago.  Now fluttery feeling in my chest) outcome was unknown.            Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was reported as not applicable.
Itchy, red rash below injection site on left deltoid.  Benadryl, Ranitidine, Triamcinolone  CRM, Medrol dosepak.
9/11/08 1545 client came to clinic was given TWINRIX under 18 yrs of age, this is his 1st dose.
Initial case was received from a physician on 14 October 2009. A six-year-old female patient, with a history of autism, experienced "regressing" or "back-sliding" in behavior after receiving an injection of FLUZONE SV 2009-2010 (lot number U3205CA) on 23 September 2009. The patient also had a history of allergy to ZITHROMAX. On 25 September 2009, two days post-vaccination, the patient's parents reported to the physician that she began experiencing regressing or back-sliding in behavior. Outcome was unknown to the reporter, and no additional information was reported. Documents held by sender: None.
Moderate R arm pain within 3 hours of injection. I found a blueish bruise when the bandaid was removed.   6 hours after vaccine:  there was a hard knot at the injection site with dark purple bruising approx 2? area on upper arm.  16 hours after vaccine:  my arm hurts regardless of activity. Arm pain is radiating down to my elbow and occasionally into my R hand.
Patient called and stated that her blood pressure was 172/100, she had a temperature of 100.4, she was dizzy and just felt awful.  That resulted in a call for an emergency squad and she was taken to our local emergency department. Also states that she was given fluids "at a rapid pace" as well as IV potassium.  As of today, 11/16/21, she is feeling better and has a scheduled virtual visit with her neurologist.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 10:33 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 10:33 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 62.64.  Concomitant medication of the patient was not reported.  Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature of 34 degrees Fahrenheit at 09:00 AM. These vials were moved to fridge on 06-Apr-2021 and beyond use date for the vials was reported as 09-May-2021. The vaccines moved to clinic on 15-Apr-2021.Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
HEART RATE SO HIGH; FEVER SO HIGH; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced heart rate so high, and fever so high. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart rate so high and fever so high was not reported. This report was non-serious.
10 min after 2nd dose of Pfizer Covid 19 vaccine, employee developed nausea, ill feeling, hot/cold and dizziness
chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking.  anaphylaxis EKG monitoring, IVF, IM Epinephrine, IV Benadryl, IV Pepcid, Albuterol dual neb,  CXR, Labs  sent home after 6 1/2 hours of treatment and monitoring. Sent home with Epi pen
Difficult to sleep; Both feet hurt; Feet were slightly swollen, but not discolored; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 24Apr2021 at 09:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient previously did not receive any medications. Concomitant medications included simvastatin (STATIN) taken for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021, Saturday morning, the patient received the shot. On 26Apr2021, Monday night, the patient noticed both his feet hurt. The patient's pain increased on Tuesday and Wednesday (28Apr2021) making it difficult to sleep on Wednesday. On Thursday and Friday, they hurt less but the patient still experienced a little hurt. The patient never had foot pain for any reason in the past, except after a long hike or other extreme exertion. The patient did not do anything unusual to make his feet hurt. On an unknown date in Apr2021, the patient's feet were slightly swollen, but not discolored and they were not sore to the touch. The clinical outcome of the events both feet hurt, making it difficult to sleep and feet were slightly swollen, but not discolored was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
23rd: hot flash/sweating within 15 minutes of receiving vaccine, Sore am, itchy throat,  horse voice; 24th: sore arm, headache,  fatigue, congestion; 25th: headache, nausea, fatigue, congestion.  26th through today - daily Headache w/nausea (OTC's not helping headaches).
Patient described her symptoms via a phone call received 11/26/2014 as the following: She had developed a large red sore (approximately 3 inch diameter) where the injection had been given. She described that her entire arm hurt once the sore had developed. Additionally that her whole hand would give a tingling sensation occasionally with the pain. The patient stated that the pain developed immediately after receiving the immunization, and the large sore and tingling was noticed within approximately 2 hours after the immunization.
Bumps on neck and around nose. Rash at around nose, itching on nose and neck.
H1N1 nasal spray given 10-23-09 at 5:00pm. Mother states noticed hives all over body at 9:00pm. Gave BENADRYL. Temp 101.7 degrees. Called pediatrician. Instructed mother to give BENADRYL 3/4 tsp. x3 daily for 5 days. Hives lasted for 4 days. Mother states that you can still see where hives were.
Headache; Chills; Congestion; Dry cough; Sour muscles; Injection site pain; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PR8735) via an unspecified route of administration in the right arm on 27Apr2021 at 11:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient was not allergic to medications, food, or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and atorvastatin calcium (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 at 12:45, the patient experienced headache, chills, congestion, dry cough, sour muscles, injection site pain, and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, chills, congestion, dry cough, sour muscles, injection site pain, and tiredness were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
p/vax pt devel inj site rxn characterized by swelling, redness & warmth;pt recovered;
This is not an adverse event report. This is a report of administration at an alternative site per the subject's request. Per the subject's request, this vaccine was administered IM to the right gluteus muscle. No adverse event was reported.
Patient said she felt immediate, strong pain in her arm from the jab the nurse gave her.  She said the needle was in her arm a lot longer than when she received her first shot.   I also watched patient receive her first COVID shot from a different provider, different facility, and I was surprised by the force of the jab of this second COVID shot, and length of time the needle was in her arm.  After the nurse left us in the room to wait 15 minutes, patient became more and more uncomfortable, hot, sweaty and nauseous.  Within 5 minutes, she was lying down on the exam table - at which time I alerted staff at the nurse's station in hallway that patient wasn't well and we needed help.  She said she would get "the provider" and be right in.  When I walked back into the room, patient was curled up in a ball on the table, pale, clammy and not able to speak.  I yelled down the hallway for help right away, and stepped back into the room.  Patient then began to vomit.  At least two nurses entered the room, and began to assess her vitals.  Her blood pressure was low, but she was breathing fine.  'The provider" (I don't know his name) came in and I told him about how hard she was jabbed, and that she began to feel badly immediately afterward.
This case meets criteria for vaccine breakthrough review. No noted COVID SxS.  Admitted to L&D for induction; incidentally screened COVID+.  Not yet given birth at time of report.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II (dose and route unknown)(lot# H020255, exp date 08-NOV-2014). It was reported that the vaccine was improperly stored vaccine (start date unknown). The outcome and action taken not provided. Additional information has been requested.
Information has been received from a Certified Medical Assistant referring to 3 patients who were over 13 years. On an unknown date, the patients were vaccinated with doses of PROQUAD (Merck) (lot# and dose not reported), subcutaneously. No adverse effects were reported. Additional information has been requested.
Xeljanz and leflunomide is not working; fatigue; This is a spontaneous report from Pfizer sponsored program. A contactable other healthcare professional and consumer (patient) reported that a 54-year-old female started to receive tofacitinib citrate (XELJANZ XR, Prolonged-release tablet, 11mg), oral from 09Dec2020 to ongoing at 11mg, once daily for rheumatoid arthritis; BNT162B2 (Solution for injection), via unspecified route administration from 28Apr2021, single dose for COVID-19 immunization and leflunomide via unspecified route of administration from an unspecified date to ongoing at an unspecified dose and frequency for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. Patient reported "changing plan with MD because combination of Xeljanz and leflunomide is not working; patient will move to Remicade but will keep taking Xeljanz until Remicade is ready to go; rheumatoid arthritis symptoms are constantly moving from joint to joint; patient had her second dose of covid-19 vaccine on Wednesday, 28Apr2021, and has been experiencing fatigue yesterday and today." MD aware. The action taken in response to the events for tofacitinib citrate was dose not changed and leflunomide was unknown. The outcome of the events was unknown.   No follow up attempts are needed. No further information is expected.
There was no adverse event. The patient was in to get the Pfizer covid booster bivalent, but instead received the Pfizeer monovalent vaccine.
Hives, patient approached nurse, hives noted on left shoulder, near injection site and right forearm. Medical director brought to assess. Benadryl 50 mg PO given to patient. Patient states that she feels warm.  Itching resolved. Hives resolved. NO longer feeling warmth or heat at site. Returning to work. Instructed to contact MD (PCP) to discuss second dose.
Patient complained of dizziness and feeling warm after immunization was administered. Patient passed out in chair.
Information has been received from a licensed practical nurse concerning a 14 year old female with no medical history or known drug allergies who on 21-JAN-2011 was vaccinated IM with the first 0.5 ml dose of GARDASIL (Lot number: 666948/0886Z). On 29-MAR-2011 the patient was vaccinated IM with her second 0.5 ml dose of GARDASIL (Lot number: 667866/1437Z; Expiration date: 25-SEP-2013). Concomitant therapy included RETIN-A and BENZACLIN. On 29-MAR-2011 the patient developed a headache after administration of her second dose of GARDASIL. Her headache improved while taking ibuprofen but returned when not taking ibuprofen. The patient sought unspecified medical attention. A complete blood count was order but results were not available yet. Upon the time of the report, the patient was not recovered. Follow up information has been received from a nurse practitioner concerning a 14 year old female "healthy" student with no known drug allergies, and no significant past medical or surgical history who at 4:08 PM on 29-MAR-2011 was vaccinated with the second dose of GARDASIL (Lot number: 667866/1437Z). On 29-MAR-2011, the patient experienced pain in neck and shoulder immediately following injection. Headache started later that evening and persisted for 1 week following injection. The patient followed up in office because ADVIL helped but headache returned when ibuprofen was wore off. The patient also took TORADOL for treatment. Complete blood count was performed on 04-APR-2011 without result provided. On 06-APR-2011, the patient recovered. Additional information is not expected.
This spontaneous report was received from a 70 year old male patient's wife. The patient's medical history included back pain. Patient had no drug reactions/allergies. On 22-MAY-2013 the patient was vaccinated with ZOSTAVAX. There were no concomitant medications. It was reported that the patient's arm, at the injection site was red and swollen. Outcome of the events was unknown. The reporter (patient's wife) touched the ZOSTAVAX injection site on her husband's arm with her hand and developed shingles over her left eye a week or two after her husband received ZOSTAVAX (Related case # 1311USA013045). No PQC was involved. Additional information has been requested.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 21-AUG-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter