chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving multiple vaccines client was advised to wait in waiting area for 10-15 minutes. Mother noticed client slumping in chair - noted client appeared to have fainted. Assisted by several staff to being placed in prone position and client color improved, and became conscious.
Titers came negative/ lack of effect; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 19-year-old patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine.  Additional information were received as follows: The age at vaccination was not reported. The patient completed the series of Hepatitis B vaccine and the titers came negative. The patient asked about the information regarding booster Twinrix dose. No further data from patient or vaccine was provided.      Lab Comments: on an unknown dat e, hepatitis B test was performed
PATIENT DEVELOPED SEVERE ABDOMINAL PAIN, N/V, FEELING FAINT LESS THAN 24 HOURS AFTER ADMINISTRATION (THE NIGHT OF 6/3/21). ON 6/4/21 PATIENT WENT TO ER AND WAS GIVEN IV FLUIDS. ON 6/5 PATIENT PASSED BLOOD CLOTS IN STOOL THAT BECAME MORE SEVERE ON 6/6/21. 6/6/21 PATIENT RETURNED TO ER AND WAS DX WITH COLITIS AND A GI BLEED. PATIENT STATES A KNOWN ALLERGY TO POLYETHYLENE GLYCOL - TOOK BENADRYL BEFORE RECEIVING EACH DOSE OF PFIZER VACCINE PER THE GUIDANCE OF HER PRIMARY CARE PHYSICIAN. PATIENT HAD NO REACTION TO FIRST DOSE.
Information has been received from a registered nurse concerning a patient who was vaccinated SC in the arm with a dose of zoster vaccine live (Oka/Merck). Subsequently, the patient experienced pain at site of injection. Six weeks later, the patient developed pain at the site of injection. The patient called the office and was monitored over the phone. No further corrective action was necessary. No further information is available.
Arm blistered from injection site to inner arm. 12cm x 9 cm in size lasting 4 days. Treatment - used ice pack and prescription skin cream.
Headache, Myalgia, Arthralgia, Diarrhea, Chills Narrative:  Other Relevant History:
On 4NOV91 pt recvd flu vax on 5NOV91 pt broke out in hives (lasting from 5th-8th) pt went to see own MD;
Pfizer-BioNTech COVID-19 Vaccine EUA: soon after vaccination patient reported dizziness and unable to maintain balance or ambulate without assistance. Patient reports a similar, milder event after the first vaccination in this series and poor oral intake prior to receiving this vaccination. Patient transported to the emergency department where inital vital signs were blood pressure 170/105 mmHg pulse of 55 beats per minute; all other vitals within normal ranges. Neurological exam was normal with dizziness and unsteady gait were noted on physical examination. Patient observed, symptoms resolved without intervention, and patient was discharged to home stable with vital signs within normal ranges except blood pressure 136/92 mmHg. On telephone follow-up the next day patient had no symptoms and was performing activities of daily living per usual.
12 hours after shot, got severe cold shakes. Had to pile blankets on to sleep but still jittering. Morning after, bad headache and sore everywhere.
Classroom Hospitalized From COVID; Classroom Hospitalized From COVID; pneumonia in his lungs; This is a spontaneous report from a contactable consumer.  An adult male patient received three doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), all via unspecified route of administration, on unspecified dates as single doses for covid-19 immunisation.  Medical history included kidney transplant in 2011 (10 years before) and he was immunocompromised. The patient's concomitant medications were not reported. The patient got covid although had 3 doses of Pfizer vaccine. COVID test showed he got covid. The reporter learned this information from a Newsweek article. Patient had fever, pneumonia in his lungs and was hospitalized. He's being treated with remdesivir and sleeping with an oxygen tube. Events required emergency room/department or urgent care.  Final outcome of the events was unknown.The lot numbers for the vaccine, [BNT162B2], were not provided and will be requested during follow up.
I received the first dose of Moderna Covid-19 vaccine on April 16th around 5pm. A small rash developed on April 25th (9 days later). It started out as a few red dots, then formed into one red blotch by the end of the day. The rash progressed from there, getting bigger each day. The rash finally resolved after 5 days (on April 29th). However I do have lasting effects from the rash, it can still be seen faintly and my skin is rougher in the area where the rash was present.   The rash itself was red, inflamed (hot to the touch), and slightly raised. It did not itch. I did not use any topical creams or oral pills to treat it.
Extreme chills, fever, headache, muscle spasms/aches, and gastrointestinal issues.  Started approximately 16 hrs after injection. Lasted for 18 hrs.  Still have pain in arm, but that was nothing compared to the other stuff.
Chills; Fatigue; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Fatigue) and PAIN (Body Aches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for an unknown indication.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced CHILLS (Chills), FATIGUE (Fatigue) and PAIN (Body Aches). At the time of the report, CHILLS (Chills), FATIGUE (Fatigue) and PAIN (Body Aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
severe adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (severe adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (severe adverse reaction). At the time of the report, IMMUNISATION REACTION (severe adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication were reported.             No treatment information was provided by the reporter.
Vaccine administered 6 hours after reconstitution...Contacted pfizer, CDC, and local epidemiologist Dr...Dr. advice was followed to consider dose give as valid and offer re-vaccination only if patient wanted.  Patient was contacted and expanded the issue offered advisement from Dr. and offered re-vaccination if wanted. No adverse reaction s/p vaccination.
Started having flareups of glassophyrengeal neuralgia within a few weeks of second dose.
Ten minutes after injection to left arm the entire arm was cold and experienced numbness, tingling and pain to left hand, which resolved approximately 8 hours later. Took 2 Tylenol extra strength 4 hours after injection. Experienced chills for 24 hours. Experienced body aches and fatigue for 4 days. By the 5th day felt better after going to acupuncture. Did not require doctor visit.
01/20/21 @ 11:00 am: Headache, chills, and body aches for 2 day. Symptoms are resolved. Feeling well.
On the morning after receiving the vaccine I had severe pain in my left hip, across my shoulders and lower back. I had a golf trip planned so I drove friends from and played 9 holes of golf that afternoon. I took Tylenol every four hours and the pain eased. I felt tired that day but the next day the pain was minor and I was not as tired.I played 18 holes of golf and played 9 on the following day and drove home. The first day of my trip when I had a bowel movement I noticed a strange acidic smell. All that day every time I ate I had a bowel movement, which is RARE for me. I usually go once in the morning. Also when I had to urinate I had to go IMMEDIATELY. The urination issue improved after the 3rd day but I continue to have the bowel problem and a mild headache and just don't feel well. I am mostly concerned about the bowel problem. I have to go every time I eat. Sometimes it is somewhat normal and sometimes it is like diarrhea.
Concerned about having a heart attack drove to the local Hospital Emergency room on 3/12/21 (Early evening). Experienced irregular heartbeats, numbness in the thumb and index finger of the right hand. Upon arrival to the ER, the Triage nurse reported EKG results showed A-FIB. I was admitted to ER. Experienced rapid heartbeat at rest and labored to breathe while waking from ER room to bathroom. Was released after test results showed no heart attack I was released and prescribed Diltiazem after a 2 to 3-hour stay in ER. Symptoms improved significantly the following day after release from ER.
Information has been received from a Doctor of pharmacy concerning a 69 year old female patient with a history of swelling to an unspecified tetanus vaccine ten years earlier, who on 05-OCT-2010 was vaccinated subcutaneously with a 0.65 ml single dose of ZOSTAVAX (Merck) (Lot # not reported). There was no concomitant medication. The pharmacist reported that on 08-OCT-2010 the patient experienced 2 inch diameter, red, possible slightly swollen area centered on the injection site. Pharmacist reported that the patient stated that the area turned red within 1-2 days of following administration of ZOSTAVAX (Merck). At the time of the report, the patient was recovering. There were no laboratories performed. The patient sought unspecified medical attention. Additional information has been requested.
got numbness in her legs; cramping in her legs sometimes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received bnt162b2 (BNT162B2), on 17Jan2022 as dose 3 (booster), single (Lot number: F13209) at the age of 55 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: bnt162b2 (dose 1, Lot number: ER8732), administration date: 02Apr2021, for COVID-19 Immunization, reaction(s): "she got numbness/numbness in her legs"; bnt162b2 (dose 2, Lot number: EW0158), administration date: 23Apr2021, for COVID-19 Immunization, reaction(s): "she got numbness/numbness in her legs". The following information was reported: MUSCLE SPASMS (non-serious) with onset Jan2022, outcome "not recovered", described as "cramping in her legs sometimes"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "got numbness in her legs". The events "got numbness in her legs" and "cramping in her legs sometimes" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoaesthesia, muscle spasms. Additional information: Patient got three Pfizer vaccines. She had numbness in her legs sometimes. She clarified that she reported this previously. After the first vaccination she got numbness and it ran with the vaccinations. She was told that it was not from the vaccinations in the ER. She just kept going and she has got numbness in her legs. They emailed her all the time and asked how she was doing and they stopped doing it. She did a report on the phone previously. Later clarified that she reported this online with Pfizer previously. They were testing her for months and months and asked how she was feeling on a scale of 1-10 and then they stopped. She called because she went to a doctor because she was still having this numbness and was told that it is probably from the vaccinations because she has been having it since then. She went online and they sent something to ask how she was doing and how many days what was going on. She reported to a chiropractor because there was numbness and cramping with her legs sometimes. She did not have cramping at time of the previous report. When she got the third vaccination it was worst.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300353354 same patient/suspect drug, different dose number/event;
Smelling exhaust fumes; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Smelling exhaust fumes) and PAIN (Soreness) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 040B21A) for COVID-19 vaccination.     Concomitant products included FAMOTIDINE for Gastric acid increased, SILDENAFIL for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced PAROSMIA (Smelling exhaust fumes) and PAIN (Soreness). The patient was treated with MELOXICAM for Pain, at a dose of UNK dosage form. At the time of the report, PAROSMIA (Smelling exhaust fumes) and PAIN (Soreness) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD21-078355 (E2B Linked Report). This case was linked to MOD-2021-080337.; Sender's Comments:  MOD21-078355:Fiance's case
Lost hearing in left ear only in early june 2021. Currenty not able to hear as before; Anatomical Location: Leg Right; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 66-years-old male patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in right leg on 24Mar2021 (age at vaccination was 66 years) as dose number unknown, single for COVID-19 immunization. The patient had known allergy to Penicillin from an unknown date. The patient did not have any other medical history. The patient did not receive any concomitant medications or other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 04Jun2021, the patient lost hearing in left ear only in early Jun2021. Currently not able to hear as before. No treatment was received for the event deafness. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests which included blood test: negative and COVID-19 test: negative on 20Aug2021. The device date was reported as 26Aug2021. The outcome of the event deafness was not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I have had serious PAIN in my heart, unable to catch breath and heart pain doesnt end., I Went to E.R. and they told me I was fine because EKG came back ok. I Have NEVER had pain let alone such pain in my heart in my life? I Feel terrible and am terrified to get second shot? I Hope someone can help me
3 days (approximately) L side of scalp began itching intensely and raised bumps could be felt. 5 days after shot a rash on L side of forehead appeared w/ intense itching and burning. 6 days after shot bridge of nose and eyelid began itching.
Initial report received on 19 September 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. This report also involved a case of misuse. A case of pertussis disease in a 4-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 2 doses of DAPTACEL; lot number C2957BA received on 26 June 2008 and an unknown lot number received on 04 May 2009 and 2 doses of PENTACEL; lot number C3176AA received on 26 August 2008 and lot number C3431AA received on 02 September 2009 (routes and sites of administration not reported). The subject developed a cough on 03 August 2012, approximately 3 years after the last dose. On 10 August 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 29 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 29 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 04 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 32 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
This spontaneous report was received from a practitioner nurse, concerning 8 patients of an unknown age and gender. There were no concurrent conditions, medical history and concomitant medications reported. On unspecified date in January 2017 (between 24-JAN-2017 and 28-JAN-2017), the patients were vaccinated with improperly stored doses of PROQUAD (dose, frequency and route not reported), lot # M031568 with expiration date of 24-DEC-2017 for prophylaxis. No adverse effects were reported. The temperature excursion of the vaccine was greater than 5 Fahrenheit degrees but less than 14 Fahrenheit degrees, for a time frame of 26 hours. No product quality complaint was involved (PQC). Data logger was involved. No further information was provided. This is one of two reports received from the same source.   Additional information has been requested.; Sender's Comments:  US-009507513-1702USA002796:
Moderna COVID-19 Vacine EUA Rapid heartbeat 20-25 minutes after injection.  Reached 112 pulse rate.  The attending nurse monitored me for about 20 minutes taking my blood pressure at least 3 times.  We even compared pulse-oximeter reading to be sure my meter was not false.  Pulse came down to 89 - normal-ish.  I left under my own power minutes later.
This spontaneous report as received from a nurse refers to a 62 years old female patient. Patient's current conditions included penicillin allergy, iodine allergy and sulfonamides allergy. On 17-SEP-2012, the patient was vaccinated subcutaneously on her left arm with a single dose of ZOSTAVAX (lot # 672675/0068AE, expiry 03-APR-2013). Concomitant medications included LUMIGAN, FLONASE, pravastatin sodium, timolol, valproic acid, bupropion hydrochloride and hydrochlorothiazide, ramipril. On 19-SEP-2012, the patient developed erythema and swelling at injection site. The patient was evaluated by the physician on 19-SEP-2012 and was found to have a 9 centimeter (cm) by 3 cm area of redness and swelling at the injection site on the left upper arm. There was no rash or blisters. The patient sought medical attention (office visit). The patient received treatment with a "Z pack", BENADRYL and cool compresses. The outcome of the events was unknown. The relatedness for the events was unknown for ZOSTAVAX. Additional information is not expected.
pt recv vax & 3wk later devel a high fever & would not eat;pt hosp;on admission WBC 18,000;devel watery diarrhea;stool cult positive for E Coli & negative for rotavirus;tx w/Rocephin;p/2 days in hosp WBC 9,700;could not move rt leg;
Experience extreme inflammatory conditions lasting now three months.  Pain in back, sacroiliac joint, leg, feet, leading to numbness and inability to walk.   Initial attempt to visit ER two days after shot.  I have never been to an emergency room prior.
Numbness for 2 days in left arm, then it went away after that. She rested and it went away.
At 1347 the recipient complained of a headache and dizziness.  At around 1400 the recipient stated he felt better and left the site.
This spontaneous report as received from a medical assistant refers to an 18-year-old patient of unknown gender. No information was provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies. On 20-DEC-2012, when the patient was 12 years old, the patient was vaccinated with the first dose of GARDASIL (exact dose, route of administration, lot# and expiration date were not provided) for prophylaxis. No adverse events were reported. On 04-JAN-2019 (reported as "now"), the patient wanted to complete the vaccination series with GARDASIL 9 (lot# and expiration date were not reported). At the time of this report, the patient was not yet vaccinated with GARDASIL 9.
REDNESS/SWELLING AROUND INJECTION SITES, INJECTION SITE HARD AND WARM TO THE TOUCH (ALL SYMPTOMS ON LEFT ARM)
8cm hard, red area around injection site. Vesicles: 1-2cm group over injection site.
redness in injection site (right); headache; muscle pain; fever 100.2 degrees Fahrenheit; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (redness in injection site (right)), HEADACHE (headache), MYALGIA (muscle pain) and PYREXIA (fever 100.2 degrees Fahrenheit) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history was reported.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Blood pressure.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness in injection site (right)), HEADACHE (headache), MYALGIA (muscle pain) and PYREXIA (fever 100.2 degrees Fahrenheit). At the time of the report, VACCINATION SITE ERYTHEMA (redness in injection site (right)), HEADACHE (headache), MYALGIA (muscle pain) and PYREXIA (fever 100.2 degrees Fahrenheit) outcome was unknown. Not Provided          This case was linked to MOD-2021-211820 (Patient Link).
Pain in arm from shoulder to hand. Left (arm only) same as shot was given. Pain more intense in joints from shoulder to elbow - wrist.
Fever (99-101 deg) Headache, bodyaches. Local swelling and pain at inj. site.
Pt presented with erythematous less than 2 cm, oval macules clustered on medial anterior left proximal bicep, mild induration w/TTP beneath, minimal visible swelling, no purulence/drainage/vesicles.
pt recvd flu vax & 16 to 24 hrs later, pt devel pain, swelling, redness, induration, & warmth @ the inject site; reaction lasted 4-5 days;
Body aches, chills, fever (as high as 101, with 800 mg of ibuprofen) , nausea. Symptoms started around 600 pm. Woke up at midnight 12/25 with a fever still and I woke up 0600 am 12/25 with mild symptoms (body aches, fatigue)
Diagnosed w/ PVCs on 6/14/21 after symptoms began in mid-May 2021.
Diagnosed with Central Serous Retinopathy on 2/1/2022 and thinning retina.   I honestly don't think this is related to the vaccine, but was told to fill out this form.
Large rash appeared on left arm in area of shot. Rash is warm to the touch. Felt slightly sick on the same day.