chrisvoncsefalvay/vaers-outcomes huggingface dataset:
white count was low; Left arm got a red rash all the way up and down, my  shoulder to mid way between my elbow and hand and some swelling; Left arm got a red rash all the way up and down, my shoulder to mid way between my elbow and hand and some swelling; my arm hurt a little bit; This is a spontaneous report from a contactable nurse (patient). An 80-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1284) on left arm, intramuscular on 02Feb2021 at single dose for COVID-19 immunization. Medical history included pancreatic cancer stage IV metastasized, blood pressure (abnormal) and chemo. Concomitant medication included pancreatin (CREON) for pancreatic enzymes. The patient previously received the first dose of BNT162B2 on 12Jan2021 for COVID-19 immunization. The patient had a side effect and it's so weird, she was a cancer patient she was in (city, state) and she had her first Covid vaccine on 12Jan2021 and she had her second one on 02Feb2021 and not a reaction until yesterday (06Feb2021) her left arm got a red rash, all the way up and down her shoulder to mid way between her elbow and hand and some swelling and she just wanted to make sure. She did look at the sheet and it does say you can get a rash, she has no temperature and she wanted to make sure that's a part of it all. When clarified if the retired registered nurse wanted to if it was the side effects from Covid vaccine, she stated, she guessed so because she got it on Tuesday and her arm hurt a little bit (Feb2021) but no rash showed up until yesterday which was Saturday. The patient had blood work done last Monday on 01Feb2021 with unknown results. The patient reported that she knows her white count was low (unspecified date) because they could give her chemo, so she actually has blood work on Monday 01Feb2021. Treatment was not received and patient stated, it just showed up yesterday and her nurse told her not to put anything on it. The outcome of the events was unknown.
Information regarding Prevnar was received from a healthcare professional regarding an unknown number of children who, since using PFS, are really screaming when given an injection. Dates were not provided. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. A physician reported that since using PFS, children are really screaming when given an injection  (screaming) (pharmaceutical product complaint). Dates and outcome were not provided. No additional information was available at the time of this report.
two days post vax pt developed an injection site reaction characterized by erythema and tenderness, and a fever. The reporter indicated that the vaccine was partially frozen at the time of administration.
Immediate 103 temperature, persistent hives continuing for now 7 days. Enormous swelling at the site of injection. Wheezing and respiratory issues. Extreme itchiness.
Parkinson's psychosis; Not received second dose; A spontaneous report was received from a consumer concerning a 76-years old, male patient who experienced the events Parkinson's disease psychosis and missed dose due hospitalization.   The patient's medical history was not provided.  Concomitant product was not reported.  On 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the anatomical for prophylaxis of COVID-19 infection.    On 26 Feb 2021, the patient experienced the event Parkinson's psychosis and was hospitalized.  The patient's second dose was scheduled on 03 Mar 2021, but he did not receive the second dose due to hospitalization.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event Parkinson's disease psychosis and missed dose were unknown.; Reporter's Comments: The events were consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
Excessive crying, redness at site, very distressed, "out of it", glazed eyes, limpness in limbs, cannot sleep, in obvious pain, won't eat much, high fever of 102.5 with Tylenol administered (night of shots). It has now been over 24 hours and still experiencing all of the above. He barely slept through the night.
redness around the injection site/discomfort, pain, itching, hardness, hot to touch and hard; redness around the injection site/discomfort, pain, itching, hardness, hot to touch and hard; redness around the injection site/discomfort, pain, itching, hardness, hot to touch and hard; redness around the injection site/discomfort, pain, itching, hardness, hot to touch and hard; redness around the injection site/discomfort, pain, itching, hardness, hot to touch and hard; redness around the injection site/discomfort, pain, itching, hardness, hot to touch and hard; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 38-years-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0178 and Expiration date was not reported), via an unknown route of administration in right arm on 22May2021 at 12-12:30 PM as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0169 and Expiration date was not reported), via an unknown route of administration in right arm on 01May2021 as single dose for covid-19 immunisation. Patient had no problems with vaccines in past as kid or since she worked in emergency services. No issues with any previous vaccines. Patient had no adverse event following prior vaccination. The patient reported that, after receiving second dose of COVID- Vaccine on 22May2021 (on Saturday as reported). On 23May2021 (yesterday as reported) she noticed a lot of redness around the whole injection site and was knowing that pain and discomfort were normal. On 24May2021 (Today as reported), it was very noticeable with redness, it was hurting, itching and hot to touch. It was also hard. So it was hard, hot, red and itchy. She wanted to ask that, if they are side effects and also to know what she could do to help with them, what would be good to take care of it or she should just let it be or what. The outcome of events was not recovered.  Follow up attempts are needed; information about lot/batch number are provided.
Pt recvd Hep B vax & devel a rash; pt was referred to an allergist for treatment; No further details were provided;
Left eye is swollen. Puffiness is around the whole eye socket, but more so below the eye. No pain, but it feels as swollen as it looks. I?ve taken one Aleve, two allergy pills (the Walgreens version of Allegra) , and used a cold eye compress. It is still swollen as of 7:47 pm ET. It has not improved that much, but it has not gotten worse. I don?t know if this swelling is due to the vaccine, as my arm feels sore but okay, or possibly a poorly timed mosquito bite in the middle of the night (as there was one in my room last night).
Fatigue  Headache  Fever Diarrhea  Sore at injection site  Treated with ibuprofen every 4 hours
Initial report received from the patient/consumer on 25 June 2012. A female patient on with pre-existing medical condition of irritable bowel syndrome and concomitant medications not reported, had received an intramuscular dose of ADACEL on the left deltoid region (lot number: unknown) on 22 June 2012. The patient received last TD in 2008. On 22 June 2012 i.e. on the same day after vaccination, the patient presented with flu like symptoms of general malaise, swollen lymph nodes and redness, swelling, pain and induration at injection site. The patient self treated herself with ibuprofen. The patient did not seek medical evaluation or treatment. The symptoms had resolved within 48 hours. Documents held by sender: none.
A week after the 2nd vaccine, I contracted shingles.; This is a spontaneous report from a contactable consumer. A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm on 26Feb2021 (Batch/Lot Number: EN9581) as 1st dose, single for Covid-19 immunisation. Medical history included mitral valve repair replacement. Concomitant medications included flecainide and rivaroxaban (XARELTO). On 25Mar2021, the patient contracted shingles. The patient was treated with valacyclovir. The outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.
Pt complained that she was not feeling well, and suddenly she turned blue and stopped breathing. EMS called, chest compressions performed. she came back.
Fridge that the vaccine were stored went out of range multiple days.  Patient's mother was notified.  Patient did not have adverse reaction.  Father will bring patient back in to get re-vaccinated.
started 10-12 hours after the shot, rapid heartbeat, chills, muscle and joint pain, headache, faint nausea, currently ongoing but improving at 36 hours
A few hours after the vaccination, I felt very tired, had a headache, shivering, fever, and muscle pain. It lasted about 24 hours and then I felt completely better. I stayed in bed and took acetaminophen. Also, my arm was swollen and painful at the injection site for about one week. I also had a flu vaccine (right arm), but I'm not sure which one so I didn't add it to the question above.
On Thursday, 5/6/21, client was to receive his first dose of Pfizer COVID vaccine (LOT #: EW0167, exp: 8/2021) at approximately 10:30am. RN  administered client's first dose in his left deltoid. Client was observed in the Observation Area for 15 minutes with no adverse effects and left vaccination site with a steady gait at approximately 11:10am. RN finished administering his 6 doses around 11:45am and returned his Participant Form for "Vial 24." RN noticed a duplication in vial number 24 forms. Upon further assessment, RN recognized that she had reconstituted the same Pfizer vial, vial 24, twice with 1.8ml of Normal Saline. Issue was elevated immediately to Clinical Lead who advised to call patient back to receive the proper full dose. Client was called at 1:15pm. RN  apologized and explained to client what happened. Client was understanding and verbalized agreement to come back at 2:30pm. Client received his first dose of Pfizer COVID vaccine (LOT #: EW0179, exp: 8/2021) on opposite arm at 2:36pm. Client denied history of severe allergic reactions. Client was observed in Observation Area for 30 minutes. Client was educated by RN on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe. Client left vaccination site with a steady gait at approximately 3:06pm.
As requested, "Moderna COVID-19 Vaccine EUA" to be included in the first line of box #18 of the report form.  Monday, 3/15/2021: 6 hours post-injection tenderness began at injection site continuing throughout entire upper arm; greater than usual fatigue.  Tuesday, 3/16/2021: woke up with a headache (which she doesn't commonly get); extremely fatigued; continued pain at injection site and throughout entire upper arm, worse than day of vaccination; exertion from activity greater than normal; nausea and dry heave vomiting around 6:30pm; felt very shaky and cold sweats; recovered from episode of nausea and weakness after an hour, but remained extremely fatigued and low on energy.  Wednesday, 3/17/2021: injection site and upper arm pain continued  Thursday, 3/18/2021: less pain in arm, but still at injection site
REDNESS AND SWELLING AT INJECTION SITE AS WELL AS MOTHER STATES "FLYING OFF THE HANDLE". DESCRIBES SYMPTOMS AS SPITTING, URINATING, AND DEFECATING ON HIMSELF. LANGUAGE ABILITIES DIMINISHED, NOT VERBALIZING HIMSELF CLEARLY COMPARED TO PRE-VACCINATION. DENIES FEVER AT THIS TIME. STATES HAD SAME SYMPTOMS FOLLOWING 07/14/2011 IMMS. DID NOT REPORT SYMTOMS AT THAT TIME TO PROVIDER BUT DID TAKE TO HOSPITAL FOR EVALUATION
States painful blisters appeared below injections site. Afebrile. Blisters burst after 2-3 days.
This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX lot # M019643 with expiration date of 20-APR-2018 or lot#M038857 with expiration date of 14-SEP-2018 for prophylaxis. Other suspect therapies included sterile diluent(manufacturer unknown). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to sterile diluent(STERILE DILUENT) and VARIVAX. The reporter considered no adverse event to be not related to VARIVAX and sterile diluent (STERILE DILUENT). Additional information has been requested.; Sender's Comments:  US-009507513-1708USA007660:
Muscle cramping in the legs. Enough to wake spouse up the first night. Then progressively worse. Now gone.
diluent only used; received diluent only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th November 2022, the patient received Shingrix. On 8th November 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-NOV-2022 Reporter's Comment: The reporter reported that, a patient received a dose of the Shingrix diluent only.  No symptoms were reported. The reporter consented to follow up. The reporter did not have any patient details or lot/expiry at the time of report. Additional Supportive Information: The reporter reported that, a patient received a dose of the Shingrix diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Tinnitus within hours of first dose which has not improved, rash on chest and left side of face after 2nd dose on 7/22.
Only sore arm for a few days; minor at injection site for additional day or two; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Aug2021 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unspecified date  as a single dose for COVID-19 immunisation. On 04Aug2021 at 15:00 the patient experienced sore arm only for a few days, minor at injection site for additional day or two. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm for few days, minor at injection site for additional day or two were resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient reported that she had chills, a fever of 101.3 deg F and she required more puffs of her inhaler in order to get sufficient air in her lungs.
went to doctor on AM of 10/10/2010 diagnosis as Acute Bronchitis Treatment with Cough Syrup W/Codeine Prednisone 20mg 2 a day 5b days Doxycycline Monohydrate 100mg 20 10days. Albuterol Sulfate 2.5mg/3ml 3 times every day
Flaccid Morbilliform rash, conjunctivitis, fever, consistent with measles - onset 12 d after MMR.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 25-NOV-2015 the patient was vaccinated with VAQTA (lot # L002717, expiration date 02-JUN-2017, dose and route not reported), which was exposed to temperatures outside of the recommended temperature (incorrect product storage). No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
Upon awakening, mother noted red area 5 inches by 1.5 inches from the injection site of Hepatitis A and HIB. Child was able to walk and was oriented to surroundings.
Subsequently post vax, the pt developed an injection site reaction characterized by redness, warmth, and discomfort. The pt recovered.
allergic reaction; This case was reported by a other health professional via sales rep and described the occurrence of allergic reaction in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received Boostrix at an unknown dose and Twinrix at an unknown dose. On an unknown date, unknown after receiving Boostrix and Twinrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Boostrix and Twinrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced allergic reaction and the patient was transferred to Medical Information department for further assistance.
Patient was administed Moderna covid19 vaccine (Lot: 03H21A, Exp 3/25/22) first dose of 0.5ml by pharmacist. All proper antiseptic techniques were performed per pharmacy/company protocol. Patient was given the vaccine around 12pm, she was directed to wait at the waiting area for 15 minutes. Patient reported back to the vaccine room around 12:05pm, she was experiencing severe lightheadedness, feeling of passing out. The pharmacy team helped her sit down. At this time she was shaking uncontrolleably, her hands were cold and clammy and she experienced difficult breathing and severe stomach upset. Patient was not able to sit upright by herself so 911 was called. EMT arrived on scene around 12:25pm. Upon arrival EMT performed tests on patient, EKG, blood presusure, heart rate, and oxygen level were normal at the time. Patient refused transportation to the hospital. ETM and pharmacist stayed with her for 20minutes. ETM asked patient to stand up on her own and she did. ETM had no further cocern, their assessment was severe anxiety attack that could be brought on by the vaccine administration. ETM left and pharmacist stayed with patient untill her boyfriend arrived to pick her up at 1:35PM. Follow up with patient will be performed in 2 days by pharmacy team.
Tinnitus.  It is now 2023, and the tinnitus has persisted.  I have had my hearing tested extensivey, and nothing is wrong with my hearing.
Bulging fontanelle morning following vaccines. Doctors recommended visit to ER. Had CAT scan to check for fluid on brain/brain swelling. Spinal tap to check for meningitis. Bulging lasted approx. 24 hours. No remaining side effects
The patient was seen for well visit on 28May2021 and noted to have significant hypertension above normal limits for age (151/95).  This was repeated and confirmed on manual reading.  The patient was asymptomatic, and record review was noted to have had normal BPs for his entire life prior to this.  Over the following week the family monitored home BPs and continued to be in hypertensive range (SBP 140s-130s) but slowly trending down over the next week.
pt given DT for a dog bite; had rxn of HTN, rash, chills, weakness & was given DPH w/good response p/30 mins; pt discharged;
I got large blister like hives, on the arm where I got the vaccine. They broke out on the lower  right arm, near the elbow and were quite large and painful. I noticed pain near my elbow, and had my SO check what it was, and it looked to him as well as to me like the above large blister like hives. I was told to take a benadryle to help, and to cgo to the ER or call 911 if things got worse.  In aprox 1 hour the pain was gone, as was the redness and swelling. I had no other adverse side effects, and seem to be doing fine.
the patient was administered improperly stored VARlVAX; This spontaneous report was received from a physician, referring to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported  On 23-JUL-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (VARIVAX) injection, by subcutaneous route (lot number S032355 which has been verified to be valid, expiration date reported and validated as 14-OCT-2021) (dosage, vaccination scheme, frequency and anatomical site of injection were not reported), as routine vaccination. The vaccine was reconstituted with properly stored sterile diluent (lot number: S032591; expiration date: 16-AUG-2022). The administered dose of the vaccine was stored at a temperature of 6 degrees Fahrenheit (F) to 14 F (13.6 F), during a time frame of 12 hours (multiple excursions); 15 F to 46 F (16.0 F), during a time frame of 30 minutes, as recorded by a digital data logger. There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA001233: US-009507513-2009USA001275: US-009507513-2009USA001278: US-009507513-2009USA001283: US-009507513-2009USA001312: US-009507513-2009USA001399: US-009507513-2009USA001677: US-009507513-2009USA001301: US-009507513-2009USA001685: US-009507513-2009USA001688:
pt recvd vax;27oct in eve,exp difficulty in breathing & eyes became blood shot;28oct devel ha,sore throat,nasal congest,watery eyes;29oct exp flu-like sxs;stayed in bed;30oct fever,chills;31oct cont to feel sick;1nov94 better;
This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding a 24-month-old male patient who experienced repeated ear infections and had a serology test that indicated the patient showed immunity only to serotype14, and no immunity to the other serotypes in PREVNAR. At 12 months of age, the patient received the fourth dose on 06-Nov-2007. On an unspecified date, the patient who has a history of ear infections and had tubes inserted prior to 6 months of age, again experienced repeated ear infections drug ineffective with the most current episode on 20-Dec-2008. The pathogen causing the ear infection was not reported. Treatment was not provided. On 22-Nov-2008, the patient was referred to an Allergist who performed a serology test that indicated the patient showed immunity only to serotype14, and no immunity to the other serotypes in PREVNAR (antibody test abnormal). The outcome of the events was unknown. No additional information was available at the time of this report.
Patient called next morning stated her tongue and throat were swollen. Had trouble breathing. Took ZYRTEC which helped after an hour. Patient informed to change Zyrtec to Benadryl q 6 hrs and make OV if not improving.
My arm is all the sudden red, warm, tender, and a bit itchy at the sight of the injection.