chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the first vaccine, she started getting them a little/after the first vaccine, caller started to have hot flashes again; She had a hormone reaction to it; affecting her mental health; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via an unspecified route of administration on 29Dec2021 at single dose for covid-19 immunization. Medical history included ongoing artificial menopause (Surgical menopause, since she was 36). The patient's concomitant medications were not reported. After the first vaccine, caller started to have hot flashes again, and after the second vaccine they became unbearable. She had a reaction to the vaccine. She had a hormone reaction to it. The caller did research herself to look up hormonal things about the Pfizer vaccine, but she could not find anything. The only information she found was on pregnancy and breast feeding, and low estrogen with COVID. They had significantly subsided over the last year and half to two years. After the first vaccine, she started getting them a little. Then, after second vaccine her hot flashes started being unbearable. She was unsure if it had to do with the vaccine, but she felt like it did. She spoke with nurses she works with. They too had hormonal issues after the vaccine. One had difficulty getting her period for 9 months to a year, but then got their period. She talked to people in menopause who have not had their period for a year, and had one after the vaccine. She talked to women with PCOS that had difficulty getting their period, but got their period after the vaccine. She also talked to women who had normal menopause, that hadn't had their period in a long time get a period. She said this was all generalized information. She doesn't have the specifics for the people that reported it. There was something hormonal going on. It was literally driving her nuts. Her first vaccine she got on the 29Dec2020, Lot number: EJ1686. Her second vaccine she got on 19Jan2021, lot number: EL9261. This all started a week after the first shot, and got worse after the second. She felt like this was medically significant. There was a fine line between medical issues and mental health, and she felt like this was affecting her mental health. Outcome of events was not recovered.   Reaction assessed: after the first vaccine, caller started to have hot flashes again, and after the second vaccine they became unbearable. Source of assessment: Primary Source Reporter; Method of assessment: Global Introspection; Drug result: Related.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  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.
COVID-19 Pfizer pediatric Bivalent vaccine for the age group 5-11 was administered to a child age 4.
05-may-2022 patient is late for the 2nd dose 1st dose was administrated on 2019/Only first dose was administrated; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-MAY-2022 Reporter's comment: The pharmacist reported that the patient was late for second dose of Shingrix. No LOT number and expiration date provided. No vaccination date provided and dob (date of birth) was provided. VAERS details were reported for 1st dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination.
swell, pain lt arm (inj site), tender sl red;stiffness of neck;t102.3 lasted about 5days much more sever & toxic than usual
Janssen COVID-19 Vaccine EUA  I received the Janssen vaccine in my upper-left arm at 3:00 PM on April 5, 2021, at a public health clinic (I think that's the proper term for the site) established in a mall. After about ten minutes, during the scheduled waiting period, I began to feel lightheaded; I can best compare the feeling to that of being tipsy after a glass or two of wine. I waited another twenty minutes at the site to see if the feeling worsened, and when it didn't, I left without telling anyone how I felt. During the drive home, however, I continued to feel lightheaded during the drive home and worried that it might be affecting my driving. After I got home without incident, the feeling persisted for a few hours and ceased that evening.  Since then, I have experienced nothing but what I think are standard post-vaccination symptoms (fatigue, muscle aches, slight brain fog, swollen lymph nodes?not unlike the sensations of recovering from a modest cold). I nevertheless want to report the lightheadedness because it appears (based on news reports) that it is an unusual reaction to the vaccine. I want to make sure that my experience is recorded, even though I do not believe that I require further medical attention.
Expired Vaccine was given on 04/11/2022 at the Doc visit. No reaction occur. No treatment was needed. Patient reports fine and no pain.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Nurse said that the patient had a screenshot of the lot number entered into the lot number expiration date check that shows the expiration date as 14-Oct-2022. The vial did not undergo any temperature excursions. No concomitant and treatment medication were provided.
Pt recv vax in 1997; in 1997 pt exp nausea, vomiting, abdominal cramping
Low grade fever and fatigue 2 days after injection, resolved in 2 days. 6 days after vaccine noted swollen supraclavicular lymph node left side, became larger, tender. 11days post vaccine node is no longer tender, slightly less swollen but still evident
Patient didn't feel well, bone pain to the extend that she felt her bones were going to crack in her feet. She has decided not to get the 2nd dose after discussing with her physician.
One week after getting the COVID-19 Pfizer vaccine, I developed congestion in my sinuses in my chest, difficulty breathing, headache. The triage nurse told me it was likely just a sinus infection and not to worry since I was vaccinated. On 9/25/21, I became dizzy, lethargic and had a terrible headache so I took a at home rapid test and the results were positive. I have an appointment today to see a respiratory doctor and I still have chest tightness and congestion as well as a bad headache.
Narrative:  COVID infection after completion of COVID vaccine series: 03/08/2021 COVID vaccine dose #1 03/29/2021 COVID vaccine dose #2 07/03/2021 Pt reported testing positive (non-agency test) 07/15/2021 COVID positive per agency nasopharyngeal swab. Pt requested testing since needed approval to go back to work. Reported exposure to close contact who was COVID positive.  07/16/2021 Pt reported development of slight, dry cough
Diarrhea; Slurred speech; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DYSARTHRIA (Slurred speech) and HEADACHE (Headache) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), DYSARTHRIA (Slurred speech) and HEADACHE (Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), DYSARTHRIA (Slurred speech) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported.
At first I got the normal COVID vaccine symptoms, I was tired, weak, and slept the first two days.  My arm got hard where the injection was. It was end of December holiday so I had to push through and try to stay awake as much as I could but I felt sick. I took off the first week of work after the New Year because I didn't feel well.  I went back to work and was dizzy and falling and had brain fog. I managed 12 physical therapy outpatient practices and several hundred employees normally and kept everything straight. When I returned after the New Year, I was very forgetful and not thinking correctly.   My legs were swelling horribly. My body was in pain everywhere. I had horrible headaches. My blood pressure was high. My heart was racing.  I didn't feel well at all. I was upset. I fell several times at work down the stairs.  I fell into the conference table. I was swelling by 10AM where I thought my legs would split open. My head hurt so bad I needed to lay down. My arm had nerve pain that started fingertips to neck that was shooting pain. This happened many times throughout the day.  Finally a manager told me on February 18, 2022 I needed to see a doctor that day. I am dizzy everyday. I have pain in my right arm. I have brain fog. I have swelling in my legs. I have pain everywhere. I have bad headaches. I am unable to work and manage the clinics I did for the past 20 years.
I informed nurse giving the vaccine that I had a mild reaction to the first injection the month before.  He noted this and informed me to have the technician in the waiting room call him if I have a similar reaction.  Within 5 minutes of being in the waiting room after receiving my second vaccine, my mouth and lips started to tingle.  Then my throat began to slowly constrict.  I informed the technician, who got the nurse immediately.  He gave me a Benadryl, took my BP and called the MD.  I was asked to stay in the waiting room for the next hour.  My symptoms never worsened.  I went home after an hour without any post events.
Local redness. Swelling, warm to touch. Benadryl 1 1/4 tsp given 6/30/03. Orapred 1 1/4 tsp given 6/30/03. Cefzil 200 mg.
Transient Global Amnesis, Headache, Confusion, inability to remember recent events, asking repetitive questions about the situation and surroundings and not recalling the answers to these questions
'Fuzzy brain' & forgetfulness lasting 24 hours. Sore arm lasting 48 hours
A filling needle was used to extract and prepare 26 doses out of a Moderna vial sequentially under 5 minutes total prep time. We are awaiting response from Moderna regarding sterility of the product. None of the possibly affected patients reported issues or adverse reactions.
My friends said I should report this, but it seemed too minor.  I had the shot on Wed, 1/27/21.  My arm ached until Sat, 1/30.  I noticed a couple of red dots on my front torso.  I didn't look anywhere else.  Sunday morning after I worked out and got out of the shower, I noticed that I had several red dots on the front of my torso and a few on both shoulders.  When I looked at my back, they were all over there as well.  I don't know whether or not they were there when I first woke up.  After a couple of hours, they were gone.  I don't know if that's because of the work out in conjunction with the shot, or if it was a fluke but felt it was better to report it than not.
Client into health dept this am c/o pain and swelling in left arm and left side of neck. Denies respiratory distress. Left arm warm to touch. Sent to ER for eval. Contacted client later part of day. Client stated "The MD put me on steroids and Benadryl. I feel better, the swelling is starting to go down."
Constant ringing of ears after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Constant ringing of ears after the vaccine) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Constant ringing of ears after the vaccine). At the time of the report, TINNITUS (Constant ringing of ears after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment details was not provided.
20 hours after vaccine began having copious vomiting, 2 episodes of diarrhea, myalgia, fatigue, and tingling to BUE
Patient received Shingrix #2 at 11:35am in left deltoid. Monitored patient X15mins. At 11:50am states she feels tingling in left index and middle fingertips. Referred patient to Dr., MD. Patient assessed and states tingling was starting to feel better. Doctor instructed patient to continue to monitor and if it tingling gets worse to return to clinic.
Patient states he has a rash over his entire body, arms and legs.  The rash is very itchy.
A physician reported that an unidentified pt received Tetanus Toxoid Adsorbed. Purogenated vaccine intradermally, instead of PPD (manuf unk) and subsequently developed swelling at the injection site. No additional info was available as of the date of this report. This is one of several patients reported by this physician to have received Tetanus Toxoid Adsorbed Purogenated vaccine intradermally. See case HQ6756804OCT2001.
reacted the day p/shot given;inj site became sore, swollen, red & warm to touch;also became leather looking
Covid arm; dizziness; chills; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), DIZZINESS (dizziness), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21a and 007C21a) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), DIZZINESS (dizziness), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea). In May 2021, VACCINATION SITE REACTION (Covid arm), DIZZINESS (dizziness), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) had resolved.            No concomitant medication was given.  No treatment medication was given.
I had TDAP shot and immediately felt nauseous, neck stiffness and fatigue. My legs felt weak and my neck stiffness has continued to worsen.
Pt recvd 2 doses of Engerix-B vax 30JUN91 & 29JUL91 & p/physical on 27AUG91 reporter indicated that pt showed elevated liver function tests; f/u liver function test is recommended in 30 days for the pt;
pt recvd vax had sweating & dizziness 3-5 mins later, nausea; 12 hrs later had arm soreness, redness, warmth w/muscle aching from neck to hands; pain & weakness of lt arm, unability to lift arms above shoulders height; sx cont  72 hrs p/vax
wouldn't nurse became pale & limp-when omitted into the hosp-was pallor & shocking;had to be hospitalized for 8 days & had 2nd blood cell transfusions
About a month after being vaccinated, I noticed something wasn't right with my stomach. I went out of town and when I came back, I still had abdominal pain and went to the doctor. They scheduled appointment for a Gastroenterologist. This has been going on for about a year.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A male patient of an unspecified age received TRUMENBA, (lot number and expiration date were not reported), via an unspecified route of administration from an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced nausea and vomiting on an unspecified date. The outcome of the event was unknown. Information on the batch number has been requested.
Patient's father reported patient's date of birth as 3/17/09 making patient 12 years old and eligible for vaccination. Patient's pediatrician office notified the pharmacy that the patient's date of birth is 3/17/11 making the patient 10 years old at time of vaccination. They verified the date of birth on the forms from his last visit, 10 year check up.
Pain in arm Drop in blood pressure  Dizziness Chills Weakness in legs and arms
Angry red rash, raised, no pustules, different in size and shape. Isolated to bilateral ankles, lower legs, appearing on bilateral outer thighs. Itchy, bleeding R/T scratching because of uncontrollable itching. Now remains very red with some scaliness around outer edges.
Vials that was put in the fridge and after that refrozen and thawed again for adult male patient; No adverse event; Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient).    This case is for 45th  patient out of 100 patient's case. Concomitant product use was not provided by the reporter. Patient received additional booster dose. 100 male patients were received bivalent booster dose. Moderna COVID19 vaccine bivalent, dosage given was in ml but was unknown to the healthcare practitioner. Also, lot number was unknown to the healthcare practitioner. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
set effusion, warmth, & lack of use of rt knee occurred p/DTP (parents not sure when); pt would not use/bend rt knee;
Got dizzy, broke out in sweat, nauseated, felt like an allergic reaction, itching all over.
Patient was given siblings vaccines. Patient did not need MMRV, HIB or Pneumo.  Vaccinations were going to be given to sibling and patient was put on the exam table.  Explained to pt. per supervisor she has had these imms. already and should not harm her had patient wait 20 mins.
This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age (gender unspecified). The nurse reported that approximately on an unknown date in November 2012, the patients may have received doses of PNEUMOVAX 23, (lot number, expiration date and route was not reported) that had been exposed to unsupportable cold temperatures. No concomitant medications were reported. It was unknown if or not any individual patient might have received more than one of the affected vaccines. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever 103.4 for 12 hours. Headache for 8 hours Fainting 2 times approximately 40 hours after shot. Chest pain 28 hours after shot, lasted for 12 hours, intermittently.  Rapid heart rate for last 3 days since shot.  Body aches and fatigue for 6-48 post shot.
Patient called stating that after the shot she got very itchy all over her body. She called her doctor and doctor recommended to take Zertec. Zertec helped but patient states the itching was for about 4 days.
Pain to site (left deltoid). Multiple Fluid filled blisters to left upper arm. swelling, redness and warmth to site.  Edema to to top of spine. Difficulty moving extremities.
Information has been received from a registered nurse concerning a female with no medical history who in approximately 1992, at the age of six, was vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently, the patient was found to have a negative titer for varicella. Unspecified medical attention was sought. No further information available. There was no product quality complaint. Additional information has been requested.
Janssen Vaccine was given to this patient who was 12 years old. He was monitored after vaccine for 15 minutes with no problems. At the end of the shift we realized that the vaccine was given to someone under the age of 18. Dr. who was on duty called and spoke to patients mother. She stated patient was doing good. She did say he had complained of mild headache but that was it. He offered patients mother to bring him in for a recheck but the mother felt he was fine and would notify us if there were any concerns.