chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cold; I don't feel well; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 07Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.   In Jan2021, the patient was on the other line and the concern was regarding her cold, the patient actually had the vaccine the day before and she had a cold right now and she is quite sick, she is asking if she can be able took antibiotic (Unspecified Medication) and asking if it may interfere with vaccine shot?". The patient stated "I have no problem with the vaccine, I am not reporting anything wrong with the vaccine, I am merely asking whether I can take a antibiotic (Unspecified Medication) because I have a cold, which I had, so what's the answer for that?". "I don't want to answer any question, I don't feel well." The outcome of the events was unknown.  Information on the Lot/Batch number has been requested
Information has been received from a woman in a physician's office concerning a 12 month old male who on 1/18/01 was vaccinated IM with a first dose of varicella virus vaccine live. On 10/19/04 at 09:00 AM, the patient was diagnosed with varicella disease in the physician's office. At the time of the report, it was unknown if the patient recovered. The patient had no adverse events following prior vaccination. Follow up information was received from the physician's office which indicated that the event was never reported as given IM instead of SC. The patient had varicella after receiving varicella virus vaccine live on 1/18/01 and varicella was diagnosed on 10/19/04. No further information is expected.
syncope , lightheaded, dizzy history of H.S.P- AUTO IMMUNE RESP 104/70,70,16, BS 122 124/68,90,16
Walking asymmetry, as if unsteady, slow to speak, foggy demeanor/slow response for 36 hr.
Low grade fever; chills; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 26Mar2021 11:00 (Lot number: EN9208) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1st, Time:11:00, Anatomical site of injection: Shoulder, Route of administration: Intramuscular, Batch/Lot number: EM9809 EUA 12-2020), administration date: 05Mar2021, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 26Mar2021 14:00, outcome "recovered" (28Mar2021), described as "Low grade fever"; CHILLS (non-serious) with onset 26Mar2021 14:00, outcome "recovered" (28Mar2021), described as "chills"; HEADACHE (non-serious) with onset 26Mar2021 14:00, outcome "recovered" (28Mar2021), described as "headache". Therapeutic measures were not taken as a result of pyrexia, chills, headache.   No follow-up attempts are possible. No further information is expected.
My body started to swell up including my face and my legs my arm and my throat; My body started to swell up including my face and my legs my arm and my throat; My body started to swell up including my face and my legs my arm and my throat; My legs were tingly; Felt like it was closing it didn't close but it was swelling up; My whole body shake like everything was shaking really bad and so I ended up going to hospital in ambulance; "via subcutaneous route"; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via subcutaneous route, administered in arm left in shoulder area on 06Jun2021 at 16:30 (age at vaccination was 53-years-old) (Batch/Lot Number: EW0196) as DOSE 1, SINGLE for covid-19 immunization. Medical history included ongoing hay fever (I take allergy medication for hay fever you know for regular allergy). Concomitant medication included gliclazide (CLARITIN) taken for hay fever, start and stop date were not reported. Prior vaccination (within 4 weeks) was reported as no. The patient stated I just wanted to report my reaction to the vaccine for record purpose. I got the 1st shot, within few hours my body started to swell up, including my face and my legs my arm and my throat. I felt like it was closing it did not close but it was swelling up and my whole body shake like everything was shaking really bad and so I ended up going to hospital in ambulance and they put me on oxygen I could breath but I think they were just worried so they put me on oxygen, and then I spent 5 days in hospital in recovering from it, I just want you guys to know when you collect your data that this was one of the side effects. Patient also stated that her legs were tingly. The event my whole body shake like everything was shaking really bad and so I ended up going to hospital in ambulance resulted in hospitalization. Period of hospitalization was reported as 06Jun2021 to 10Jun2021 (duration 5 days). When asked patient if still experiencing events, the patient stated no, I am fine now, in the hospital they pumped with a lot of fluid and including lot of electrolyte, I had follow-up visit with my doctor and I am very healthy now I am fine, I think they just needed to flush it out of my system. The outcome of the events was recovered on an unspecified date in Jun2021.  Information on the lot/batch number has been requested.
Case number PHEH2015US002807, is an initial spontaneous report from a nurse received on 04 Feb 2015. This report refers to an 11-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was administered only MenCYW-135 liquid component of MENVEO (batch number: M14071) without being reconstituted with MenA, intramuscularly on 04 Feb 2015 without any reports of harm due to the administration error.
Second shot administered Inadvertently before 21 days. Patient walked into to get second dose of Pfizer covid-19 vaccine in the Second shot vaccine clinic at high school clinic event. Upon screening patient said she have received the first dose of Pfizer covid-19 vaccine during the first clinic we did 3 weeks ago on 07/20/21 at the school. Patient said she doesn?t have a record card from first dose. She has been administered the second dose of Pfizer covid-19 vaccine. While writing record card for second dose, she produced the card from first dose. According to that, she has been administered first dose of Pfizer covid-19 vaccine on 08/05/2021 by other vaccine administrator at the school. We have checked immtrac2 registry of state for first dose record but did not find any record of first dose of Pfizer covid-19 vaccine till 08/12/2021. Patient was under observation for 30 minutes and did well during that period. We informed patient and guardian(mother) to watch for any side effects she may experience and contact her physician if symptoms persist. Patient and mother both were informed not to get third dose of Pfizer covid-19 vaccine, as her 2 dose series is completed as per CDC guidelines.
Symptoms after 2nd shot done 2/9 : of fatigue , increased pain to joints and intense (femur)bone pain x 2 days . Fevers started 2/15/21. Bronchitis diagnosed 2/17and treated with zpack Fevers continue from 100.3-102.1 documented since this 2/15/21 Average at least 2-4 days per week  Overall Increased pain /fatigue - worse than prior to shots
a little harder to breathe; some chest heaviness; This is a spontaneous report from a contactable consumer (patient) reported herself.   A 25-years-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Batch/Lot number: ER8737) via an unspecified route of administration in left arm on 20Apr2021 at 11:00 (age at vaccination 25 years and non-pregnant at the time of vaccination) as dose 2, single for COVID-19 immunisation. The patient's medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) and paracetamol (TYLENOL); both were taken for an unknown indication from an unknown date to unknown if ongoing. The patient previously took z-pak and experienced drug allergy. The patient previously received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number: EN6205) via an unspecified route of administration in left arm on 15Mar2021 at 14:00 as dose 1, single for COVID-19 immunisation and experienced lot more joint pain since first dose (achy, throbbing, tingling in hands, feet, arms, knees). On an unknown date in Apr2021, the patient woke up night of 2nd dose noticed it was a little harder to breathe, this really has not gone away and some chest heaviness. There was no COVID prior vaccination. There was no COVID tested post vaccination. Adverse events resulted in doctor or other healthcare professional office/clinic visit. There was no received any treatment. The outcome of events was reported as not recovered. No follow-up attempts are possible. No further information was expected.
About 15 to 30 mins after vaccine wait time I started to pass out, heavy chest, shortness of breath, elevated heart rate, dizziness, and light headed was told in ER I was having allergic reaction. Was kept for observation
This spontaneous report as received from a pharmacist via RMPDC refers to a 68 year old male patient. The patient's medical history included occasional colds. The patient's relevant past drug history was unknown. On 05-NOV-2013 the patient was vaccinated with the first dose of ZOSTAVAX (lot#, dose, route not reported). On 31-OCT-2014 the patient was vaccinated with the second dose of ZOSTAVAX (route not reported, lot # J012657, expiration date 10-JAN-2015, dose 0.65 ml). Concomitant therapies included testosterone (manufacturer unknown) and influenza virus vaccine inactivated (unspecified) which was given on 31-OCT-2014. It was reported that the patient's wife phoned the pharmacy later and said she did not know what the patient was doing because he got one ZOSTAVAX last year. The patient's relevant tests or laboratory data was unknown. Additional information has been requested.
This spontaneous report as received from an other health professional (Registered Nurse) refers to unspecified patients of unknown age and demographics. Current conditions and medical history was not reported. On 06-OCT-2014, patients were vaccinated with (Oka/Merck) VARIVAX injection, subcutaneous for an unknown indication (dose and frequency was not reported). Concomitant medications were not reported. It was reported that doses of improperly stored (Oka/Merck) VARIVAX was administered to unspecified patients on 06-OCT-2014. The was supported. NO adverse effects reported. Product quality complaint was not reported. This case is linked to 1410USA010179 (same reporter). Additional information has been requested.
Approx 5 days after shot my son developed a runny nose followed by fever.  We took him to his doctor immediately.  Doctor gave him antibiotics and told me to come back next day.  Next day doctor evaluated and ordered a hospital stay.  A day later son was trasported by ambulance from one hospital to another hospital.  Required intubation and 11 day hospital stay.  Total of 12 days in hospital.  MR received from local hospital for a direct admit for increasing respiratory distress and resistance to eat/drink on 10/17/2006. Rocephin, Zithromax, and Xopenex neb started 1 day prior to admission. PE: Congestion with noisy respirations noted.  T'=100.6'F. Nasal congestion with mucoid d/c. Swollen tonsils. Cervical adenitis. Respiratory intercostal retractions, wheezing and rales bilaterally. Tachycardia. Still having problem with visual alignment of the eyes. Impression:  1) Acute bronchopneumonia 2) Acute tonsillitis and cervical adenitis 3) dehydration.  01/22/2007: MR received from treating hospital after transfer.  HPI as above, child had runny nose x1-2 weeks which progressed to fever and a deep,  hoarse cough.  He was transfered to this hospital for further treatment. Despite treatment with steroids, antibiotics and neb treatments he continued to show increased respiratory distress( intercostal retractions, flaring nostrils, and increased need for O2)  which neccessitated a broncoscopy.  Erythema of the airway was noted c/w tracheitis.  He was intubated and transfered to PICU. He was extubated 3 days later, however required a protracted course to return to full consciousness, and decreased eye/hand co-ordination was noted.  Neurology consult was done. He gradually improved and was discharged on day 10. Discharge Diagnosis: Viral Tracheitis.  02/22/2007 MR received from PCP.  15 month well baby check on 10/10/2006 where baby received DTaP and Prevnar.  Most recent MMR and Varicella on 07/13/2006 (not 10/05/2006 as stated on VAERS report from parent).  PE WNL except continued problem with his vision still noted.  Child must accomodate his eyes when he is going to focus on something. Next visit is 10/16/2006 with c/o fever (103'F), with coughing and nasal congestion.  PE  showed tonsils to be bright red and swollen.  Lungs sounds with rhonchi, gross rales, and a few fine rales on both lung fields.    DX: Very severe tonsillitis. Bronchopneumonia.  TXd with Rocephin IM and po Zithromax. Seen the following day (10/17/2007) for Acute Bronchopneumonia, tonsillitis, dehydration and admitted to hospital. (See above). F/U exam 10/30/2007 follwing hospital D/C.  PE: shows lungs clear, and mild nasal congestion. Two more episodes of tonsillitis in November and several reports of diarrhea.  An influenza syndrome in December. Several episodes of runny nose, cough, and wheezing in January and February. DXs include: rhinitis, upper and lower respiratory infections.
Pt recvd vax 19JUN91 & on 20JUN91 devel fever 104, arm red, swollen & sore; Was not responsive to APAP & ice; Visited ER told to continue w/APAP & ice; Later became nauseated & reported to family MD who drained sore area (infected area);
Seen on 5/6 for 1 yr WCC, got varicella, MMR, Hep A shots.  Started last night with fever and extreme fussiness.  Then Mom saw a few red bumps on her legs.  This morning the rash had spread to involve both her legs, is blistering, and there are a few blisters next to her mouth.  She continues to be very fussy. Ate breakfast okay this morning.  Only other exposure Mom can think of was that she was in the gym nursery over the weekend.
09/01/2021-Noticed that my right shoulder and mention the joint pain in the shoulder, still same pain, so much that I could not sleep. I went back to the ortho on 09/08/2021 Cortisone injection in that shoulder. I doing a PT for about several weeks, now I had an MRI scheduled because the PT is not working. On 11/05/2021 MRI- I have fraying and probable digenite labrum. I am not back in PT and ongoing. Just started back on 11/29/2021.
Gardasil vaccine #3 on 9-2007; On morning of 9-24-07 woke up dizzy, pale, unbalance, headache, change coordination-Referred to Neurologist-eval 9-26-07 Had Exam, MRI Brain, Labs, EKG-Follow up visit with PCP on 10-25-07. 10/26/07-records received for DOS 9/26/07-neurology consultation. Impression vertigo and near syncope. May represent a begign post infectious type phenomenon. Little odd in that they occur episodically rather than with movement. Three episodes of veritgo and near syncope have occurred in last 6 weeks. No positional type veritgo. Occasional headache after episodes. Some shortness of breath with episodes.
Pt started to experience itching all over her body after 7 days getting her 1st dose of Covid vaccine.  She said that the symptoms lasted about 1 & 1/2 to 2 weeks.  Pt said she used hydrocortisone cream over the counter for itching.  When she received her 2nd dose of Covid vaccine, brown spots started to show up at lower back and thighs.  Currently the brown spots  do  not itch and spots are fading away, but the spots look dry.
Severe headache ongoing all day; body and muscle aches all day; extreme fatigue all day; dry cough over 4 hours; temperature of 100.3 for several hours, dizziness all day; diarrhea twice in the evening; sore throat all day
This is a spontaneous report from a contactable 94-year-old female consumer reporting for herself. A 94-year-old female patient received PREVNAR 13 intramuscular at 0.5ml, single on 01Oct2015. Medical history included renal disorder (she had only one good kidney, the other is working on at 5%), blood pressure high, lung cancer from 2001, arthritis, diphtheria (she had diphtheria when she was young), voice box was paralyzed (her voice box was paralyzed because of diphtheria), leaky valves (treated with COUMADIN), heart rate irregular (treated with CARDIZEM). She had to stop taking Glipizide since she was having bladder infection that was due to the Glipizide and she also was having swollen ankles, that has gone down to normal. Concomitant medication included DIOVAN 80 mg, 2x/day from 2001 and ongoing for blood pressure high, CARDIZEM 120 mg, 2x/day started before 2000 and ongoing to regulate the heartbeat, COUMADIN 4mg every day, except for the 2mg on two days ongoing for leaky valves. She was taken Digoxin and PRONESTYL, it did not work anymore. Since PREVNAR 13 vaccination, she has experienced throat problems and one day she could not talk in 2015. She was diagnosed with pneumonia a month or so before this report (she was unable to remember exact date). She also experienced the throat problems within a couple months after having the vaccination. She also had weak legs in 2015 a month after getting vaccination. On 13Feb2016, she had 2 TIAs, where she had garble speech. She will have a MRI relating to her garbled speech. The outcome of TIA was unknown: she stated she was getting a little weak, but there was an age factor also. The outcome of pneumonia and one day she could not talk was recovered. The outcome of throat problems and weak legs was not recovered.
Information has been received from a Certified Medical Assistant concerning an 18 month old patient who on an unspecified date was vaccinated with a first dose of MMR II and a first dose of VARIVAX (Merck) at age 12 months. And both were repeated 6 months later. The patient was now 18 months old. No adverse symptoms noted. Follow-up information has been received from a Certified Medical Assistant concerning a patient with no illness at time of vaccination, no preexisting allergies, birth defects and medical conditions and no adverse events following prior vaccinations. On 26-JUN-2012, the patient was vaccinated with dose 2 M-M-R II, SC (lot # 1023AA), dose 2 VARIVAX (Merck), SC (lot # 671341/1250AA), ACTHIB, PREVNAR and DAPTACEL. No adverse symptoms were noted. No lab test were performed. Additional information is not expected.
Booster; Hair started falling out; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included Bnt162b2 (Dose 1, Pfizer BioNTech Covid19 Vaccine), for COVID-19 immunisation, reaction(s) Hair started falling out; Bnt162b2 (Dose 2, Pfizer BioNTech COVID19 Vaccine), for COVID-19 immunisation, reaction(s) Hair started falling out. The following information was reported IMMUNISATION (non-serious), outcome unknown; ALOPECIA (non-serious), outcome unknown. The clinical course included she received all three Pfizer BioNTech Covid19 Vaccine doses, but after the first dose she noticed her hair started falling out. After the second dose, her hair started falling out more. Then it stopped and everything seemed ok. Then she got the booster and her hair started falling out again. She has questions. The caller noticed the hair failing about within a month of the first dose. She noticed hair everywhere. Certainly, after the second dose, it was like woah.   The lot number for bnt162b2 was not provided and will be requested during follow-up. Linked Report(s): US-PFIZER INC-202101595915 same reporter/drug/AE, different patients.
Resident tested positive to COVID 19 by PCR test on 3/18/21.  Lab run twice to ensure positivity.  Resident asymptomatic
LEGS CRAMPING FROM CALVES DOWN TO HAMSTRINGS, BILATERALLY BUT WORSE ON THE LEFT SIDE; MUSCLES TIGHT; SORE LEG; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient did not have known allergies and no comorbidities and no breastfeeding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced legs cramping from calves down to hamstrings, bilaterally but worse on the left side. On 12-APR-2021, the subject experienced muscles tight. On 12-APR-2021, the subject experienced sore leg. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, and fever on 05-APR-2021, had not recovered from legs cramping from calves down to hamstrings, bilaterally but worse on the left side, and sore leg, and the outcome of muscles tight was not reported. This report was non-serious.
Severe pain upon administration 10/5/2020 pain with every movement couldn't take shirt off (still can't without pain), hurts to lift certain ways, tingling & pain down arm to hand 10/16 called Dr primary physician Dr referred me to another Dr. 10/19/2020 X-rays Left shoulder Celestone Soluspan 6-3 MG/ML susp Lidocaine Injections Injection/aspirations LT major jt. 11-4-2020 MRI Shoulder left wo contrast 11-16-2020 Dr recommend PT. 11-30-2020 P.T. 12-2-2020 P.T. 12-7-2020 P.T. 12-9-2020 P.T. 12-14-2020 PT. 12-16-2020 PT. 12-21-2020 PT. 12-21-2020 Dr Celestone Soluspan 6-3 MG/ML susp Lidocaine Injections Injections/aspirations LT major jt. 1/4/2021 Still have pain taking off shirt and sleeping and lifting certain ways.
After about 6-7 minutes I started feeling hot and my throat felt very thick, it was hard to breathe in, the felt tremendous pressure in my chest.   I alerted the staff and they gave me benedryl and epinephrine.  An ambulance came and took me the ER.  I was given more epinephrine and other meds, solu -medrol,   I stayed in the hospital from 4/5 - 4/9. I am now at home under my doctor?s care, off work until April 30th.   I still feel ill, coughing spasms, hurts to breathe, very fatigued.
Mother of patient called on 4/19/05 to report child vomiting x4 and decreased appetite.  Reports child vomits when attempting to give Tylenol but only during that time.  Reports child still drinking juice fine but refused milk and solid foods. Reports pt is more fussy and irritable today as well.
Red raised lump with pain on left bicep.  Extreme fatigue, achy joints, swollen under arm lymph nodes and burning in breast.  That started on 2/6/21 1 week post vaccine.