chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient recently left vaccine observation area and noted she was "I am feeling funny/weak and that she had just obtained the COVID vaccine." with pre-syncopal episode. Patient taken to ED for evaluation.  Given IV fluids and discharged from ED.
About 2 hours after the 2nd dose, I was extremely tired and slept the whole weekend. I had a fever 103, no appetite, diarrhea, arm pain, body aches, and nausea. The symptoms did not go away so I consulted with my doctor who instructed me to keep an eye on it. On day 3, the symptoms increased and I could not eat or drink and I felt very nauseas so I decided to go to the ER. I was given an IV and I was admitted for a total of 7 days. They ran a bunch of tests and labs and everything came back normal. I was discharge with instructions to keep hydrated. I am still suffering from nausea, diarrhea, and body aches. The symptoms have not improved over time and have not resolved.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Nausea-Mild
Within 30 minutes of receiving the vaccine, I experienced mild chest tightness and a mild cough. Later that day I experienced fatigue, headache, and chills. The next day I felt like I had the flu but went to work anyway.  I became lightheaded and nauseous at work and was sent home.  I spent all day in bed with a fever of 100 degrees, chills, and fatigue.  The fever persisted until about 10 pm, at which time I began to feel better. My arm is also extremely red and sore at the injection site.
This spontaneous report was received from a register nurse concerning an unspecified number of patient on unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL (lot number, expiration date and route were not reported) dose 3. Register nurse reported that on an unknown date an unspecified number of patients may have been administered GARDASIL with an interval of only 8 weeks between dose two and three. No adverse effects reported. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 02-JUL-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J011339, expiration date 13-DEC-2014) (route of administration and dose were not reported). No adverse effects reported. Additional information has been requested.
was nursed by mother who received Pfizer COVID vaccine; one twin who kind of gets allergic reactions to vaccines; body rash; Low grade fever; fussy/ fussiness; This is a spontaneous report from a contactable other health professional (HCP) (patient's mother). This other HCP reported information for both mother and babies (boy girl twins). This is a baby report (girl twin). A 14-month-old female patient received the first dose of BNT162B2 (Lot# EJ1685), via transmammary on 16Dec2020 at single dose for COVID-19 immunization. The patient medical history included like for the 12 month appointment, she got 4 to 5 shots, and got a full body rash and fever for a couple days, but it's hard to say, like she got a flu shots and whatever ones that go with it. There were no concomitant medications. The patient was nursed by mother who received Pfizer COVID vaccine. The patient's mother got her first dose of vaccine, later clarified as the Pfizer COVID vaccine, on 16Dec2020, and she was nursing twins, they are about 14 months now. She had boy girl twins and the patient was shorter than her brother, since she was a girl. She was normal height, in the 50th percentile for age. The patient's mother had no adverse effect, she had normal side effects, and one twin (the girl) who kind of gets allergic reactions to vaccines, like body rash and fever, nothing serious, the other one (the boy) has no issues. Afterwards the twin who gets side effects, was fussy and had a low grade fever, but nothing serious, and she was encouraged to report to Pfizer, she didn't know if this is significant, or anything to worry about with the second dose. The mother stated her daughter was fussy that afternoon, on 16Dec2020, the mother had nursed before she left, say around 10:30 AM, and probably nursed her around 3 PM, afterwards, and the next time she nursed, she was fussy, by early afternoon/evening a couple hours after nursing, The fussiness was just that day and evening, and her daughter has the low grade fever that evening was 16Dec2020. Caller gave her some infant tylenol and it went away, and comforted her, since she got fussy, and it went away that evening. Stated the next morning she gave her the tylenol as well and she was fine. Stated the pediatrician might have that if Pfizer wishes to contact, but she thought maybe after MMR, probably what she had gotten, the problem was she had so many at once, so it's hard to say which ones, like for the 12 month appointment, she got 4 to 5 shots, and got a full body rash and fever for a couple days, but it's hard to say, like she got a flu shots and whatever ones that go with it. Stated it's interesting, the two kids to compare, her son doesn't usually get vaccine reactions, her daughter does, and it's interesting he was completely fine and she was fussy. The outcome of the events low grade fever and fussy/ fussiness was recovered on 16Dec2020. The outcome of the other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020518603 baby case (boy twin);US-PFIZER INC-2020518990 maternal case
5 year old male patient developed injection site inflammation after received Daptacel, in the left leg on 08/16/2005.  The patient also received Ipol, in the right leg on the same day.  On 08/17/2005, he had left leg swelling and redness.  He did not have a fever.  His leg was hot to touch.  There was a swollen length of the leg.  He was seen by his doctor on 08/19/2005 and treated with Tylenol.  At the time of reporting, the patient did not recover. Follow up information received from a healthcare professional on 09/12/2005.  At the time of this report, the patient had recovered.
Imm. given 9/23/15 with no reaction. On 9/24/15 mother called stating child had low grade fever and rash. Was seen and given steroid injection. Pt waited in office x4 hrs. Regularly checked on. Rash disappeared. Pt went home with parent and apt to be seen 9/25/15.
This case was reported by a consumer via other manufacturer and described the occurrence of jaundice in a adult female patient who received TWINRIX. On an unknown date, the patient received TWINRIX adult at an unknown dose. On an unknown date, 3 years after receiving TWINRIX adult, the patient experienced jaundice, bilirubin increased and elevated liver enzymes. On an unknown date, the outcome of the jaundice, bilirubin increased and elevated liver enzymes were unknown. It was unknown if the reporter considered the jaundice, bilirubin increased and elevated liver enzymes to be related to TWINRIX adult. Additional details were provided as follows: About 3 to 4 years after receiving TWINRIX, the patient experienced elevated bilirubin and liver enzymes. She also developed jaundice. The patient declined to provide her physician's name or demographics. No additional information was provided.
Information has been received from a physician via a company representative referring to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, expiration date, strength, dose, frequency and route were unknown). The patient's concomitant medication was not reported. On 2014 the patient developed shingles 2 years following administration of ZOSTAVAX on an unspecified date. The outcome of herpes zoster was unknown. The causality between the event and ZOSTAVAX was not reported. Additional information has been requested.
Client report receiving first COVID vaccine on 03/22/21.   Received second COVID vaccine on 04/16/21, exact time not known but was in the afternoon.  Adverse reaction started to be slightly noticeable after first vaccine of a rash or acne on lower back around waist line.  Reaction more noticed after second vaccine on 04/17, rash noticed to be steadily growing.  Rash noted to be slightly itchy, warm to touch, and painful.  Client seen by PCP on 04/21/21, given diagnosis of Shingles and prescribed Valtrex.  Client will continue to monitor rash and take medication as ordered.
Pain in arm (not in the one where the shot was administered), dizziness, earache, feeling out-of-it, felt would lose contol of arms, achiness in joints;
Pain and lymph node swelling in right side neck; pain in armpit; General body soreness; discomfort; Soreness in right arm; lymph node swelling in right side neck and armpit; headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: er8727,) via an unspecified route of administration in the right arm on 22Mar2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had a history of allergy to codeine. The concomitant medications were not reported. The patient did not receive any other medications or vaccines within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 22Mar2021, the patient experienced soreness in right arm, pain and lymph node swelling in right side neck and armpit, general body soreness, discomfort, headache, and fatigue. The patient did not receive any treatment for reported events. The clinical outcome of pain in arm, swollen lymph nodes, lymph node pain, armpit pain, general body pain, discomfort, headache and fatigue was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
10 min. was fine, then all of a sudden my whole body felt flushed and overcome with nausea, light headedness, ,my face was hot and had an overall feeling of being unwell. It is hard to describe.  I did not think I could drive home safely, so I sat back down and told the girl. She let me sit quietly and than took my blood pressure which was either 185 or 189.  She let me rest and then took it again.  This time it was 167.  I left there about 8:30a.m., came right home and went to bed.  Got up after a long nap and B.P. was 165/82 61 at 6:45p.m. My face is still flushed, have chills and slight headache, took aspirin.  At 9:45 B.P. was 150/92 64, felt the same.  B.P. at midnight was 130/73 73
Staff states hives appeared in evening after receiving vaccine in the afternoon. Next day itching/hive continues reported to work but itching was bad went for treatment to ER. Course of treatment unknown, discharge paperwork states: allergies.
Patient was mistakenly administered 3rd dose of COVID-19 Pfizer Vaccine.  1st Dose: 12/23/2020 2nd Dose: 01/13/2021 3rd Dose: 02/01/2021
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 01Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initially only ssore arm pain but 3 to 4 days later I was struck with extreme pain in my lungs and upper back. 5 days later I seem to recover from days of pain but no fever. Just really sick for five days where I could only stay bedridden. I have never had any type of sickness like this except for a severe case of pneumonia in 2014 which took nearly one year to recover. This pain and reaction to the shot was similar but fortunately  short lived. I hope this does not happen again when I go back for the booster shot on May 3rd.
11/10/19 and 11/11/19 - fever, chills, body aches 11/12/19 to 11/15/19 - muscle aches, particularly across middle of chest and back; general malaise 11/16/19 sever back pain, rash from center of back around left side to center of chest.  Urgent clinic - doctor diagnosed as Shingles and prescribed Valtrex and pain medicine (narcotic) As of the date of this report (11/19/19) the rash has continued to deepen in color (red) with some blisters.  Body aches have begun to subside, but still active.
Spouse reported that it started as a "minor rash" under the arms or "few bumps". Spouse reports that it "slowly worsened" and by Friday it was "much worse" and had "hives" all down the arms to the waist and on the chest. Tried generic "Benadryl" on Friday that helped the itching but did not significantly improve the hives, so also tried "Zyrtec that did not touch it". She continues with "hives" today without change.
For the first 24-48 hours, the patient reported chills and pain near the injection site.  Over the course of the first 48 hours, these symptoms diminished. On the morning of the 3rd day post-vaccination, the patient awoke with redness on the upper arm that was injected as well as describing it as warm/hot. Over the course of today, the 3rd day post-vaccination, those symptoms also began to diminish.
Patient received a second booster (3 total) of Janssen vaccine before it got approved. Patient experienced AEs at the time of administration. Will follow up with patient 1 day after, 1 week after and 1 month after the shot.
Intense pain in the left arm, burning, and a kind of erythema that covers the area where the vaccine was given and spread to the elbow. with a sensation of heat to the touch.
pregnant received Moderna COVID 19 vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant received Moderna COVID 19 vaccine) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (prior use) on 14-Mar-2021.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 23-Feb-2021 and the estimated date of delivery was 28-Nov-2021. On 18-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant received Moderna COVID 19 vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 18-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant received Moderna COVID 19 vaccine) had resolved. 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.   Concomitant medication use was unknown Treatment information was unknown
Started to have stiffness and swelling in my right toe early Sunday morning. I thought I was maybe bit by a bug or had a reaction to the salt water pool (as I was out of town). When I awoke that Monday, my toe felt hot and swollen. It appeared like the skin was stretched. The site was red and sensitive to the touch. As the day progressed, I called my insurance. The same reaction appeared on my left index toe as well.
Worsening redness, swelling, itching, warmth ... started around the injection site, but spreading now covers 75% of upper arm.
This spontaneous report as received from a Medical assistant refers to a patient of unknown age. The patients was inadvertently administered an incomplete dose of ROTATEQ (dose and lot # not reported) on 29-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. An unspecified nurse was administering the dose of ROTATEQ when the patient started choking after receiving "about one or third dose". The patient did not regurgitate but the nurse did not administer the remainder of the ROTATEQ dose. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (Very sore arm/ extreme soreness) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 002MOA) for COVID-19 vaccination. Family history included Osteoporosis. Concurrent medical conditions included Depression, Anxiety, Cystitis interstitial since 2016, Asthma since 1998, Keratitis since 2008 and Antiphospholipid syndrome (Carrier of) since 05-Feb-2020. Concomitant products included ENOXAPARIN SODIUM (LOVENOX [ENOXAPARIN SODIUM]) for Anticoagulant therapy, BUSPIRONE for Anxiety, MONTELUKAST for Asthma, ACETYLSALICYLIC ACID (BABY ASPIRIN) for Blood disorder, DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (BONJESTA) for Nausea, CALCIUM for Osteoporosis, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 27-Sep-2020 and the estimated date of delivery was 04-Jul-2021. On 20-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (Very sore arm/ extreme soreness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (Very sore arm/ extreme soreness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medication was not reported. This case was linked to MOD-2021-026999 (Patient Link).; Sender's Comments: This is a case of product exposure during pregnancy with AE Vaccination site pain for this 30-year-old female. Based on current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Patient received the 1st dose / on 29Apr2020 and is late for 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on 29th April 2020).   On an unknown date, the patient received 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 details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. When asked consent for follow-up, the healthcare professional stated he would need to check with patient. The healthcare professional did not consent to follow up
Pt stated that his arm was red, swollen, and painful starting the night of the injection. Advised the patient to take BENADRYL, and ibuprofen and the swelling has gone down since then.
After receiving the Pfizer Covid booster, broke out in full body rash/hives, about 36 hours after.
Information has been received from a physician concerning a 16 week old female who was vaccinated with Rotateq.  Subsequently, the patient experienced bloody stool.  The patient sought unspecified medical attention.  Upon internal review, bloody stool was determined to be an other important medical event.  This is one of two reports received from the same source.  Additional information has been requested.
PATIENT EXPERIENCED ONE INCH WHEAL ON THE EVENING OF 1-8-2012. BY THE AM OF 1-9-13, PATIENT HAD A 3 INCH RED SWOLLEN LUMP THAT DID NOT ITCH OR CAUSE PAIN.
STOMACH PAIN; This spontaneous case report was received from a nurse on 08-Mar-2019. It described a female consumer who had stomach pain following the intake of Vivotif for an unknown indication.  It was reported that the consumer had stomach pain after taking the second, third, and fourth dose of Vivotif.  The action taken with Vivotif with respect to the event stomach pain was dosage maintained.  The clinical outcome of the event stomach pain was unknown.  Company's Comment: In this case, it was reported that a female consumer had stomach pain following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, stomach pain is labelled as per agency. Hence, the causality of the event with Vivotif is assessed as possible ; Sender's Comments: Company's Comment: In this case, it was reported that a female consumer had stomach pain following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, stomach pain is labelled as per agency. Hence, the causality of the event with Vivotif is assessed as possible
COVID 19 Treatment; COVID 19 Treatment; Dose 2: Moderna; Dose 1: Janssen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 3 (booster), single (Lot number: GH9694) at the age of 49 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Oct2021 as dose 2 (booster), single (Lot number: O12F21A), in right arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 11Apr2021 as dose 1, single (Lot number: 207A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Other medical history: Hypothyroidism; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; LEVOTHYROXINE; VITAMIN D3. Past drug history included: Vagisil, reaction(s): "Known allergies: vagisil", notes: Known allergies: vagisil. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Sep2022, outcome "unknown", described as "Dose 2: Moderna; Dose 1: Janssen"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient received other medications in 2weeks.