chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two days after receiving the vaccination, the patient stated that the injection site was red, warm to the touch and tender. She drew a circle around the injection site to see if the redness was expanding, and said that the redness did spread (no time frame was given). She stated that she had reached out to her PCP who had been unresponsive up until the time that the patient was contacted by lab. As of 1/19/22 she stated that the redness is mostly gone but there is still some heat at the injection site, and she is continuing to wait for a response from her PCP.
Extreme swelling, increasing throughout weekend, fever and leg painful and hot to touch. Patient would not eat or play, just wanted to lay around. Felt bad.
Sick the day after the 2nd shot with 101 fever, chills, aches, etc .   Felt fine for 4-5 days after that.  Then, nausea, fatigue and fever set in.  Have experienced low-grade temperature, nausea and some fatique for several days now.
Fever, headaches, upset stomach, panic attacks, diarrhea, depression, sleeplessness, memory loss, chronic fatigue, tremors, eye problems, weight gain, eczema, and irritability post vax. Follow up report received 7/6/01: MD report indicates pt has adenocarcinoma of cervix in situ that appears to be completely excised.
Mother has an internal itch; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (reported as 99, unit unknown) received her  first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller wanted to know if there will be an interaction between the Pfizer COVID-19 vaccine and betamethasone injection. Reporter is calling for her mother who has received the first dose of the COVID-19 vaccine and is scheduled for the second dose a week from today. Because her mother has an internal itch, her mother's doctor gives her betamethasone. She had conflicting recommendations from her mother's doctors and wanted to know Pfizer's recommendations. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Fever 100-101, severe headaches, chills, nausea, diarrhea, body aches, bones hurt through out my whole body, weakness, fatigue.  This lasted 2 days.  One bought of dry heaves.  Then 3 days of weakness and fatigue as though I had the flu.
Dizzy immediately  following shot, continued off and on for several hours, about 10 hours in my chest began to tighten and my rib cage became sore and was painful to take a deep breath. Developed a fever shortly after, chills, sweating, nausea, and headache, inability to sleep.  Still dealing with same issues 5 hours after they started, will call primary care office when they open if symptoms don?t subside.
Pt was apprehensive about receiving 2nd dose d/t throat swelling, heart palpitations after 1st dose.  she was seen by health professional and was advised that she should receive 2nd dose.  2nd dose was given at approx. 1720. At 1745 pt stated she was feeling her throat closing  just like after 1st vaccine. She was able to talk and swallow water without difficulty.  Her throat was viewed by vaccine lead via flashlight and appeared normal and open.  Vital signs were BP 100/64, P-60 and O2 sat 100%.  Benadryl, 25mg was given along with water and verbal encouragement.  Pt refused to lay down.  At approx. 6:10 pt was talking without difficulty, throat was again visualize by vaccine lead and this RN and appeared normal and open.  Stated "throat still feels swollen." Denies lip or tongue involvement and is able to swallow without difficulty.  VSS at this time were BP 134/75, P-65 and O2 sat 100%.   pt stated she was okay to leave and refused to be escorted out of building stating she was fine.  Boyfriend was waiting in car to drive pt home
Fast heartbeat all day; A spontaneous report () was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fast heartbeat all day/palpitation.  The patient's medical history was not provided.  concomitant products use were not provided by reporter. On 26 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 007M20A) via unknown route for prophylaxis of COVID-19 infection.  On 7 Feb 2021, the patient experienced the event(s) fast heartbeat all day.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 7 Feb 2021 the outcome of event,  fast heartbeat all day was resolved.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
I had the vaccine, got shingles anyway/Suspected vaccination failure; I got shingles anyway, in my 5th week; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18th Apr 2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient had the vaccine and never had chicken pox. The patient got shingles anyway. The patient was in 5 th week. Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not given. The follow up would not be possible since no contact details provided.
This spontaneous report was received from a nurse referring to patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies of patients were not reported. On 02-AUG-2016, the patients were vaccinated with warm VARIVAX injection (doses, frequencies and lot# not reported) subcutaneously after shipment was received. The agency advised her today that VARIVAX vaccine should not be administered. No patients have reported adverse effects. There was no product quality complaint (PQC) involved. Additional information has been requested.
Headache which she described as more of starting on her neck going up to her head/ She feels a little bit of a headache, more neck than head; Headache which she described as more of starting on her neck going up to her head/ She feels a little bit of a headache, more neck than head; This is a spontaneous report from a contactable consumer, the patient. A 84 years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown) on Jan2021 as a single dose, for COVID-19 vaccination. The patient medical history and  concomitant medications were not reported. On Jan2021,the patient experienced  headache which she described as more of starting on her neck going up to her head/ she feels a little bit of a headache, more neck than head. Patient stated  this is normal for her, she often gets headaches. Consumer commented that she thinks it is not necessary for her to call her HCP about it when it is something that she can take care of herself.  'Wants to know if taking either Tylenol or Advil would interact with the vaccine and did mention that she has taken the medications yesterday (unclear if patient had taken medications before or after receiving vaccine). The consumer (patient) unwilling to complete the report. The clinical outcome of headache and neck pain was unknown.    Information about Lot number has been requested.
I started having a sore throat and skin sensitivity all over muscle/joint aches all over. It hurt to put on pants, and this lasted for about 24 hours and then I did a COVID-19 test at home and, I was positive. I contacted a doctor as soon as I tested because I have asthma and chest/lungs were tight and I was having issues breathing. The doctor gave me PAXLOVID, and I was told to increase my inhaler uses and I was told to go to an urgent care center so they could listen to me. I started the medication January 4th. When I went to urgent care, they added methylprednisolone as well as my inhaler. Over time Jan11, I saw my doctor because the symptoms were weakening and to check my lung function. The doctor tested everything as far as my lungs and whatnot she increased PULMICORT because I was just about out. Then on 01/15 I woke up with worsening symptoms, so I tested again and except the sore throat these were all new symptoms. The COVID-19 test was very bold with a positive reading whereas the last test was positive a faint sign. So, 8 days later I tested again and was negative for COVID-19.
Metallic taste; sore arm; This is a spontaneous report from a contactable consumer (patient). This 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EP7533) on 12Apr2021 05:45 PM in right arm at single dose for COVID-19 immunization. Medical history included epilepsy, bradycardia, hypothyroidism, trigeminal neuralgia, allergies to sulfa. Patient was not pregnant, not pregnant at the time of vaccination. It was unknown if the patient diagnosed with COVID-19 prior to vaccination. Concomitant medications within 2 weeks of vaccination included levothyroxine sodium (LEVOTHROID) and acetylsalicylic acid (ASPIRINE).The patient previously received levetiracetam (KEPPRA) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced metallic taste and sore arm on 12Apr2021. No treatment received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Within 8 hours of the Pneumonia vaccine, I had body aches and a 100 temperature. This lasted 3 days. Then I felt serious fatigue the fourth day. I slept for 24 hours. It still was not enough. On the fifth day, my arms and legs felt like they were burning. Days 6, 7, 8, 9, 10, 11, 12, 13, 14, I would lay in bed for 4 hours before I could fall asleep. The burning sensation in my arms and legs continued. Day 15, 16, 17, as I write this hurts less.
Patient got red swollen arm with streaks, went to ER 12/4/2017 got ROCEPHIN shot and now on KEFLEX.
Muscle pains; led and joint pain; led and joint pain; sore throat; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Sep2021 17:45 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Latex" (unspecified if ongoing), notes: known allergies: Latex. Concomitant medication(s) included: PRO-AIR; DULERA; VIT D [COLECALCIFEROL]. The following information was reported: MYALGIA (non-serious) with onset 24Sep2021 19:30, outcome "not recovered", described as "Muscle pains"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 24Sep2021 19:30, outcome "not recovered" and all described as "led and joint pain"; OROPHARYNGEAL PAIN (non-serious) with onset 24Sep2021 19:30, outcome "not recovered", described as "sore throat". The events "muscle pains", "led and joint pain", "led and joint pain" and "sore throat" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of myalgia, pain in extremity, arthralgia, oropharyngeal pain.  Additional information: Patient facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store.Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No.What treatment received for the adverse event: Continue taking your meds.Prior to vaccination, was the patient diagnosed with COVID-19: No.Since the vaccination, has the patient been tested for COVID-19: No.Reason why batch/lot is Unknown: Wasn't written on my card.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Little bruise around the arm; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Little bruise around the arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced CONTUSION (Little bruise around the arm). At the time of the report, CONTUSION (Little bruise around the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a physician concerning a 15 year old female patient who was vaccinated with a third dose of Gardasil.  Concomitant therapy included MENACTRA.  Subsequently the patient broke out in hives.  The physician stated that after each of the three doses the patient broke out in hives.  The reaction became worse each time.  Unknown medical attention was sought.  The patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Headache, Myalgia, NauseaVomiting, arm sore on injection side Narrative:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 16-DEC-2015, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as zoster. The patient was prescribed valacyclovir (VALTREX) for management of her painful symptoms. On or about 21-MAR-2016, the patient sought subsequent treatment from a physician for a persistent and severe vesicular rash, which was diagnosed shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a father regarding his 8-year-old son who experienced a rash, described by a nurse as Fifth disease. At 8 years of age, the patient received a dose on (date not specified). Medical History: Relevant medical history was not provided. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on (date not specified). Dose regimen was 1 dose. Concomitant Therapy: Concomitant medications were not reported. Event Details: On 19-Dec-2003, post-immunization, the child developed a rash, first on his cheeks, and then on the rest of his body, mainly his arms and legs. The rash was described by a nurse as "Fifth disease". No additional information was available at the time of this report.
This spontaneous report as received from healthcare worker refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA lot # L023936, expiry 15-MAR-2017 (dose and route not reported). No adverse effects reported. No additional information was provided. Temperature: 32 F. Time frame: 3 minutes and back in range. No previous temperature excursions reported. Data logger was used. This case is one of the 3 reports from the same source. Additional information has been requested.
Dizziness, Myalgias, Fever & NauseaVomiting Narrative:  Other Relevant History:
Five days post vax, the pts mother found blood all over the pts bed, soaked 1/4 of the sheets, through the mattress pad to the mattress. Mother found an open sore in the pts nose. Later that day the pt had a rash on her back. The following day the pt had a stuffy, runny nose. Subsequently the pt had more bleeding from her nose and found another open sore developing. A doctor visit was requires. The most recent information reports the condition of the pt is unknown.
3 days after getting the vaccine he started constantly sleeping and not waking up to eat. He won?t open his eyes and just screams. He?s awake for very short periods of time.  I took him the the ER and was brushed off and was told that babies sleep.
Vaccine given on 3/25/02. Mother stated on 3/27/02, she noticed "red spot on child's right side of face and right side of arm. By 3/28/02, right arm spots spread. On 3/29/02, the child had red blotches on right upper arm, across upper back and shoulders and across face. Took child to MD and was given Benadryl and Claritin. Mother to monitor and report any new symptoms.
Redness, warmth, swelling, soreness,p ain at injection site, headache, fever, pain in left shoulder and dizziness.
throat began to swell; hives in several spots; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 12:00 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to sulfa. Concomitant medication included venlafaxine hydrochloride (EFFEXOR) for unspecified indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021 at 16:00, approximately 28 hours later, the patient experienced hives in several spots and throat began to swell. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events hives in several spots and throat began to swell and included treatment with 2 benadryl at onset. The clinical outcome of the events hives and throat swelling was recovered on unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Bad headache, temp 101, arm and legs ache. No swelling or reddening of arms Patient was given Aleve with no relief. Patient was told to continue Aleve/Tylenol and up the fluids
Developed nausea, hives, itching, and rash about 2 hours after injection. Went to urgent care for tx on 10/1/16 in the AM. They gave steroid injection/cream. Patient has been on BENADRYL every day since until today 10/7/16. Symptoms have been waxing and waning since injection. Patient had previously had same injection (FLUZONE HD) in 2015 with no problems.
some pressure in her unspecified ear; partial loss of hearing; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (some pressure in her unspecified ear) and HYPOACUSIS (partial loss of hearing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced EAR DISCOMFORT (some pressure in her unspecified ear) and HYPOACUSIS (partial loss of hearing). In January 2021, EAR DISCOMFORT (some pressure in her unspecified ear) and HYPOACUSIS (partial loss of hearing) had resolved.     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.   Acetaminophen (TYLENOL) was reported as treatment medication.
This spontaneous report as received from two pharmacists refers to an "approximately 61 years old" female patient with celiac disease, wheat allergy and previous anaphylaxis to lidocaine (date unspecified), and "101 others". On 24-APR-2013 the patient was vaccinated with a single dose of ZOSTAVAX (lot # H019996, expiration date unspecified) single dose, 0.65 ml, subcutaneously (anatomical location unspecified). The pharmacists reported that on 24-APR-2013, the patient had an immediate anaphylactic reaction after receiving ZOSTAVAX involving chest pain and shortness of breath. The pharmacist reported that the patient had a previous anaphylactic reaction to lidocaine that was very similar to the reaction that occurred with the administration of ZOSTAVAX. The patient was taken to emergency room and was admitted overnight for chest pain and decreased respiratory quality, she received treatment with epinephrine (manufacturer unknown), IV drugs unspecified. At the time of the report the outcome of immediate anaphylactic reaction was reported as recovering. Immediate anaphylactic reaction was considered to be serious due to hospitalization, medically significant and life threatening by the reporter. Additional information has been requested.
4 expired doses administered to four patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 expired doses administered to four patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 expired doses administered to four patients). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (4 expired doses administered to four patients) had resolved.        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.   No concomitant medication was reported.