chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Since the vaccine: nerve issues including tingling and pain, heart palpitation/racing heart beat, burning in arms and shoulders, anxiety, depression, weakness, dizziness, itchy skin, sun sensitivity, heat sensitivity, brain fog, exhaustion/fatigue, tremors, tight chest
Fever -99.8F- chills, headache, ache at site of injection, sore arm, muscle pains, joint, especially hands, pain, fatigue, dizziness lack of appetite.
This case was reported by a healthcare professional and described the occurrence of redness below injection site in a 55-year-old female subject who was vaccinated with FLUARIX Quadrivalent (GlaxoSmithKline). Concurrent medical conditions included allergy to PERCODAN, codeine allergy, TREXIMET allergy and sensitivity to latex. Concurrent medications included WELLBUTRIN, ACIPHEX, SINGULAIR, Doxepin and RHINOCORT. On 4 September 2013 (after 12:30) the subject received a dose of FLUARIX Quadrivalent (.5 ml, unknown route, left arm). On 5 September 2013, 1 day after vaccination with FLUARIX Quadrivalent, the subject experienced redness below injection site. The healthcare professional indicated that the event was considered to be a local injection site reaction. At the time of reporting the event was unresolved. The healthcare professional considered the event was possibly related to vaccination with FLUARIX Quadrivalent. Follow up received on 25 September 2013. The healthcare professional documented that the events resolved on 9 September 2013, 5 days after onset of redness below injection site. The healthcare professional indicated that FLUARIX Quadrivalent was the suspect product. The healthcare professional did not consider the event serious.
Large welt about 6-8cm with erythema and pain, at time of medical observation 2 weeks later it had decreased to 4cm
Information has been received from a practice manager concerning a 12 year old female patient who on 16-MAR-2010 was vaccinated with one dose of GARDASIL (Lot # 663559/1178Y). The practice manager reported that the patient experienced edema of the extremities. At the time of this report, the patient had not recovered. It was unknown if the patient sought medical attention. Additional information has been requested.
Patient reports feeling ill since he got flu shot on 11/06/13. He has been feeling dizzy, has low temperature 95 degrees.
Patient was given FluZone intradermal vaccine, first dose did not fully penetrate the skin and a large amount of vaccine was visible dripping down his arm. Therefore a 2nd dose was given and this dose entered the intradermal space creating a wheal. Within 10 min patient reports left facial itching and tingling as well as feeling light-headed. He presented to his PCM clinic. A physician examined him and noted no redness or swelling of either the face or site of vaccine administration. Patient voiced concern about a possible "vaccine overdose". He was reassured and released home.
Severe edema of left arm and left breast, axillary and subclavicular lymphadenopathy. Left arm pain, left shoulder pain, numbness and tingling in left upper extremity. No significant improvement after 6-day steroid dose pack.
About 8/9 days after first shot I noticed a pale pink/red rash on arm around injection sight.  The rash was about 3 x 2 inches in size and maintained the same light color for duration.  I applied Benadryl cream 2 days after noticing rash and the rash lightened and went away.
CHIEF COMPLAINT:   pt comes from home, alone. reports he fell out of bed today around 10am. was able to get up on his own after 6 hours. complains of "my bottom hurts". is not on any meds at home. does have bump on left forehead area. dried blood left ear.   HISTORY OF PRESENT ILLNESS:     94-year-old male with no reported past medical history presents for fall at home.  Per his son they think that he fell possibly around 10 AM this morning out of bed hitting his ear on the nightstand.  Patient son states that they arrived to his home at approximately noon to 1 PM.  Patient was already up at that time and open the door for them.  Patient himself has no concerns or somatic complaints other than sacral pain.  He has been having this ongoing for greater than a week according to his son.  Son states that he is unable to stand and ambulate.
This is a solicited report from a contactable consumer (patient) via a non-Pfizer sponsored program received by Pfizer. (Mfr. Control No.: 21K-163-3852938-00). A 60-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), intramuscular on an unspecified date (at the age of 60-year-old) as single dose for covid-19 immunisation and adalimumab (HUMIRA, solution for injection in pre-filled pen), subcutaneous from an unspecified date at unspecified dose and frequency for moderate to severe ulcerative colitis. The patient received first dose of bnt162b2 (manufactured by Pfizer) intramuscular on an unspecified date as single dose for Covid-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient experienced intestinal bleeding on an unspecified date. He had Intestinal bleeding after second dose of bnt162b2. The patient never had bleeding since taking adalimumab. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Blood was hardly noticeable after ten days. He had no pain and no cramping. The event was considered serious as other medically important condition. The action taken in response to the event for bnt162b2 was not applicable while for adalimumab was unknown. The outcome of the event was recovering. The patient's causality for the event intestinal bleeding was probable for bnt162b2. AbbVie's opinion was that there was no reasonable possibility that the event of intestinal bleeding is related to Humira.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The 60-year-old male patient had underlying disease of severe ulcerative colitis and was with treatment of adalimumab (HUMIRA). The reported intestinal bleeding after second dose of bnt162b2 was most likely due to his underlying disease of ulcerative colitis, and unlikely causally related to bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Headache, Fever (99F), Ache in joints (+1 days from 2nd dose and lasting 2 days)  Burning Rash on Torso, Back, Neck and Arms (+8 days from 2nd dose and still ongoing)
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 26-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 which had a lot number of L001312 and expiration date on 24-FEB-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL 9 vaccine had a temperature excursions of 48 hours. The highest recorded temperature was 52 F (11.11111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
A mass dosage administration error incident occured on 06/23/2022.  Undiluted Pfizer Pedi Covid vaccine, was administered to 19 children with age range from 5yr to 11 yrs.  Each child previous entered in VAERS on  06/24/2022.    Assigned case number are listed below for future reference.  860054 859865 859879 860009 860051 859881 859877 859874 859898 859912 859870 859860 859992 860014 859892 859858 859887 859888 859907
broke out with hives everywhere all over my body; everywhere, from head to toe; she experienced hives (not warts) and itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4401058.  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) at the age of 59 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset 2021, outcome "not recovered", described as "broke out with hives everywhere all over my body; everywhere, from head to toe"; PRURITUS (non-serious) with onset 2021, outcome "not recovered", described as "she experienced hives (not warts) and itching".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received H1N1 vaccine at school. One hour after taking vaccine drove from one place to another when c/o chest pain/dizziness, rash, pruritis, L side numbness. To ER via ambulance. Treated and discharged to home @ 13:00. D/C to home 11/4/09.
RASH OF BLOOD COMING TO SURFACE OF SKIN; RASH ON ARMS AND FOOT; ALLERGIC REACTION TWICE; This spontaneous report received from a patient via a company representative concerned a 58 year old of unspecified 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: 1808986 expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced rash of blood coming to surface of skin. On JUN-2021, the subject experienced rash on arms and foot. On JUN-2021, the subject experienced allergic reaction twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the allergic reaction twice, rash of blood coming to surface of skin and rash on arms and foot was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
At 7:10 am on 4/14/21, I first started shaking uncontrollable because I was so cold w/ chills. Then about 7:30 am I started breathing hard. My eye sight went black for a few minutes, I almost passed out. Both hands went numb for a few minutes. Then I got a fever, highest was 102.7. Had fever off and on all day and body aches then by 2 pm the fever was better. Then at 7:30 pm, I started shaking again and my fever spiked to 104.5.  I got it down to 103 and it was like for about 3 hours then it broke. Then for about a week, I was very exhausted and had no energy and couldn't like normal, no appetite. It took me a week to get to feeling better.
cough, sore throat, cold sweats, congestion, shortness of breath due to coughing, headache, body aches, taste is off, smell is off, nausea, diarrhea.  starting 1/1/22
PCV7 0.5 ml sub-q right arm given on 12/2//05. 12/30/05 at 16:00 received call fro mom. Inj. site red with 3 1/2" - 4" diameter. Temp 99.8. Advised ice pack and ibuprofen. Call on call physician if necessary.
Severe swelling and pain in lymph node regions of left side of body( shot given in left arm) including left under arm/armpit, left breast region, side of left check, left shoulder, left upper back, left neck, left collarbone region and upper left chest.
The evening after receiving vaccination pt states that her fibromyalgia condition became activated. Sensation of tingling started at injection site and moved throughout pt's body in a controlled fashion ending down at her feet. Sensational continued throughout week and continued to grow stronger. Then, 2 weeks after pt began to feel uncomfortable pressure in her arms and legs from the inside out. Then symptoms progressed to pain and inflammation in knee joints. As tingling and pain began to resolve in extremities over the course of a month, pt began to have uncomfortable gastrointestinal sensations similar to mild diverticulitis. Knee pain has resolved. Bloated feeling in extremities has resolved. Pt still has overall tingling sensation as well as gastrointestinal uncomfortableness.
She had the COVID; She had the COVID; Almost passed out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She had the COVID"; PRESYNCOPE (non-serious), outcome "unknown", described as "Almost passed out". The event "almost passed out" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Clinical course: The consumer (patient's mother) reported that her daughter (patient) was one of the first one that came down with it, she almost passed out and she was taken to the emergency room. She had the COVID on an unspecified date.  The lot number for BNT162B2 was not provided and will be requested during follow up.
there is a huge place on his arm about 3 inches around that looks like blood comes to the surface.; This spontaneous case was reported by a patient and describes the occurrence of PURPURA (there is a huge place on his arm about 3 inches around that looks like blood comes to the surface.) in a 72-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031278) for COVID-19 prophylaxis.     The patient's past medical history included Heart attack in October 2022. Previously administered products included for Product used for unknown indication: Pfizer (First dose) on 08-Oct-2021, Pfizer (second dose) on 13-May-2022, Pfizer (3rd Booster dose) on 14-Sep-2022, HPV (3 to 4 weeks ago) and Flu vaccine (3 to 4 weeks ago). Past adverse reactions to the above products included No adverse event with Flu vaccine, HPV, Pfizer, Pfizer and Pfizer. Concomitant products included SACUBITRIL, VALSARTAN (ENTRESTO) for COVID-19 prophylaxis, CARVEDILOL, EZETIMIBE, ASPIRIN [ACETYLSALICYLIC ACID], HYDROCHLOROTHIAZIDE and ATORVASTATIN for an unknown indication.    On 28-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 28-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced PURPURA (there is a huge place on his arm about 3 inches around that looks like blood comes to the surface.). At the time of the report, PURPURA (there is a huge place on his arm about 3 inches around that looks like blood comes to the surface.) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.
Case PHEH2016US028814 is an initial spontaneous report received from pharmacist on 01 Nov 2016. This case refers to 21 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 168805, expiry date: Apr 2017) at a dose of 0.5 ml intramuscular on 15 Oct 2016. On the same day, it was reported that the patient received FLUVIRIN following a temperature excursion of 47.5 Fahrenheit (F). The vaccine had been given since first excursion. No adverse event was reported following this medication error.
swelling / to thee injection site; redness / to thee injection site; tenderness to thee injection site; skin burn; scar tissue; This case was reported by a consumer via media and described the occurrence of injection site swelling in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 15th November 2020, the patient received Boostrix. In November 2020, less than a week after receiving Boostrix, the patient experienced injection site swelling, injection site erythema, injection site tenderness, burn and scar. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site tenderness, burn and scar were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site tenderness, burn and scar to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Boostrix and caused swelling, redness and tenderness to the injection site in the left deltoid, followed by skin burn and scar tissue.  The reporter asked what could did for that.
Information has been received from a physician concerning a 15 year old female with a history of fainting/syncope with every vaccination at the onset of age 4 to 5 years old, who on 29-JUN-2007 was vaccinated intramuscularly with the second dose of Gardasil (lot # 657621/0387U1). Concomitant vaccination on 29-JUN-2007 included the first dose of MENACTRA (lot # U2227AA) intramuscularly. There was illness at the time of vaccination. The patient's father also had a history of syncope during injections. It was reported that following the vaccinations, the patient passed out (unconscious) times two minutes. The patient "turned pale, the passed out, fainted". Her vital signs were good during the episode (RR=22, HR=78, oxygen saturation=98% on room air). The patient was allowed to rest with her legs elevated in an air conditioned room times 30-45 minutes. It was reported that a previous physician had sent the patient to a specialist and that an echocardiogram and EKG were within normal range. The patient subsquently recovered then went home.No further information is expected.
Severe Arm pain -- now lasting for a week and not ending.  Extra strength Tylenol has helped very little.
Sore throat; runny nose; sneezing; This is a spontaneous report from a contactable pharmacist (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EN6208), via an unspecified route of administration, administered in the right arm on 10Mar2021, 16:45 (at the age of 36 years old) as first dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had no other vaccines four weeks prior vaccination and was not pregnant by the time of vaccination. Concomitant medications included cetirizine and multiple vitamin. The patient experienced sore throat, runny nose, and sneezing on 11Mar2021. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Therapeutic measures were taken as a result of sore throat, runny nose, and sneezing and included treatment with benzonatate and cough/cold syrup. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
pt recv vax & 90% of the patients exp pain @ inj site post vax;
Pt received vaccine felt light headed lowered to floor 96HR 99% no respiratory distress, no allergic rx, no loc.  EMS called pt declined transport vs wnl FSBG 93 EMS left and pt lightheaded again lowered to floor MD/EMS called and pt taken to the hospital
No adverse effects were reported; inadvertently administered an expired dose of MMR II; This spontaneous report was received from a physician referring to a patient of unknown age and unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided.   On 29-MAY-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) (lot # N014483 and expiration date 10-MAY-2019) subcutaneously for prophylaxis (expired product administered). No adverse effects were reported.
pt recvd vax 1130AM; 20DEC95 1030PM fever was 104 ax;mom gave sponge bath, motrin, DPH;430AM temp was 102-cont to go down was back to nl the next day
No other AE details available at this time; Caller reported temperature excursion. / Temperature -1 3.3C; This spontaneous report was received from a registered nurse concerning to a 4-year-old patient of unknown gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.  On 17-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), 0.5 milliliter (ml) for prophylaxis, lot number reported as T021638 and expiration date as 21-DEC-2021 (vaccination scheme, route of administration and anatomical site of vaccination were not provided). No additional adverse events were reported.  The administered vaccine had a temperature excursion of -13.3 degrees Celsius (°C) for a time frame of 4 hours and 15 minutes on an unspecified date, and the data was recorded by a digital data logger. It was also reported there was not a previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA013095: US-009507513-2012USA013584: US-009507513-2012USA013603: US-009507513-2012USA013093: