chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received booster dose instead of the full 3rd dose.; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Received booster dose instead of the full 3rd dose.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A and 037K20A) for COVID-19 vaccination.     Concomitant products included ADALIMUMAB (HUMIRA) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received booster dose instead of the full 3rd dose.). On 05-Nov-2021, ACCIDENTAL UNDERDOSE (Received booster dose instead of the full 3rd dose.) had resolved.            Patient is considered immunocompromise because she is taking Humira. At the time of getting the booster she did not know she should have received the full 3rd dose. When she went back to her doctor, he told her she should have received a full 3rd dose. Batch number for second dose is Lot #: 042L20A OR could be 042C20A No treatment information was provided.
This case was reported by a physician via a sales representative and described the occurrence of cellulitis in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received booster dose of BOOSTRIX (unknown). At an unspecified time after vaccination with BOOSTRIX, the subject experienced cellulitis. The physician considered the event was clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified.
First dose of Phizer vaccine at 5 weeks pregnant (due date 12/25/2021). The following day I lost all pregnancy symptoms (nausea, fatigue, breast soreness). I had no symptoms for over a week and also experienced some unusual discharge (light pink, mucus on 4/24&4/25). Blood test to check HCG levels showed they were increasing but not quite at the rate the should have been. 5/5 ultrasound showed baby measuring correctly and with a heartbeat, pregnancy symptoms were beginning to return. Correlation/causation? I'll never know but I very much wish I had waited until my second trimester to vaccinate.
Pain came back a week after the shot during the night. Felt like the day I got it and day after (sore ).   1/25/21  Woke in morning and arm was very sore and itchy at the injection site. Rash, warm, hardened, and swollen. Took 1/2 a benedryll at 6:30am.. About 9:55am got very itchy again. 11:35am no change in itchy and seems to be more sore and warm. Arm is actual achy and sore from shoulder to finger tips. Rash has gotten worse and more red through the day. Took 2 ibuprofen and 1/2 benedryll at about 12pm.
Patient states in increase in redness and pain at injection site on right upper arm.  Rash noted to neck and face, no swelling of tongue.
Body aches, headache, chills, soreness in arm.  Resolved in about 12 hours
RN administered vaccine on 09/19/2023 and the Vaccine expired on 09/16/2023. Patient to be notified, vaccines have been pulled and discarded.  RN has been reminded to check expiration dates on all medications/vaccines given to patients.
Should/arm/deltoid is sore, there is a red slightly inflamed spot about 3 inches long  and 1 in wide. Patient did see their provider and said it is nothing to worry about and should go away.
Allergy - itch in ears ., face  back throat felt a bit tight on one side swollen a bit and nose inside felt swollen took a Benadryl there blood pressure was high
On 1/26/00, the pt developed a "moderate case" of chickenpox that consisted of an unknown number of lesions and a fever of 101.2 fever. The pt sought unspecified medical attention and was treated with calamine, camphor, hydrochloride and calamine lotion.  Follow up information from a registered nurse indicated that the pt's rash was "generalized pruritic, and vesicular and the pt had a low grade temp." The pt subsequently recovered.
severe entire body rash; little bit of rash in both injections; redness around the injection site; skin rash/ irritation; Has not been able to sleep for weeks; Itchy scalp/itchiness; eye almost 2 weeks swollen; gout in his knee; cyst in his left eye; body beeing completely abnormal/ scratching; body beeing completely abnormal/scratching; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (skin rash/ irritation), INSOMNIA (Has not been able to sleep for weeks), PRURITUS (Itchy scalp/itchiness), EYE SWELLING (eye almost 2 weeks swollen) and GOUT (gout in his knee) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information  was reported.  Concomitant products included FISH OIL for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced SKIN IRRITATION (skin rash/ irritation), INSOMNIA (Has not been able to sleep for weeks), PRURITUS (Itchy scalp/itchiness), EYE SWELLING (eye almost 2 weeks swollen), GOUT (gout in his knee), CYST (cyst in his left eye), FEELING ABNORMAL (body beeing completely abnormal/ scratching), SCRATCH (body beeing completely abnormal/scratching), VACCINATION SITE RASH (little bit of rash in both injections) and VACCINATION SITE ERYTHEMA (redness around the injection site). On an unknown date, the patient experienced RASH (severe entire body rash). At the time of the report, SKIN IRRITATION (skin rash/ irritation), INSOMNIA (Has not been able to sleep for weeks), PRURITUS (Itchy scalp/itchiness), EYE SWELLING (eye almost 2 weeks swollen), GOUT (gout in his knee), CYST (cyst in his left eye), FEELING ABNORMAL (body beeing completely abnormal/ scratching), SCRATCH (body beeing completely abnormal/scratching), RASH (severe entire body rash), VACCINATION SITE RASH (little bit of rash in both injections) and VACCINATION SITE ERYTHEMA (redness around the injection site) outcome was unknown.            Concomitant medications also included supplements and Vitamins.  It was reported that patient consulted dermatologist but couldn't ruled out the nature of skin rash and its cause. Patient reported that he didn't experience such adverse events before  until the vaccine administration.  Treatment medication included steroid topical cream for reducing the itchiness irritation.   This case was linked to MOD-2021-294290 (Patient Link).
Screaming reaction, post vax with pertussis, which lasted approx. 6-8 hours.
Participant reported nausea and throat swelling after receiving vaccine/ no epi administered/ 911 called, participant was not transported to hospital/NURSE called pt a ride home.
Described as intermittent electric shocks "nerve shocks", numbness, tingling, pins and needles feeling in fingers. Diagnosis: Idiopathic polyneuropathy.  Treatments have included Pregabalin, corticosteroids, muscle relaxers.
Day of vaccine chills and headache. Next day sore bicep, hurts with any movement, red and swelling at the injection site.
pt recvd vax on 28FEB93 & approx 2 wks following vax pt devel a viral synd manifested by a fever of 103, malaise, myalgia & tooth pain; exp arm & shoulder pain & rapidly progressed to quadriplegia by 25MAR92; dx transverse myelitis;
She states that a child received the yellow label dark pink cap 0.2 ml/10mcg dose as a first and/or second dose; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (She states that a child received the yellow label dark pink cap 0.2 ml/10mcg dose as a first and/or second dose) and NO ADVERSE EVENT (No adverse event) in an infant male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (She states that a child received the yellow label dark pink cap 0.2 ml/10mcg dose as a first and/or second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (She states that a child received the yellow label dark pink cap 0.2 ml/10mcg dose as a first and/or second dose) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (She states that a child received the yellow label dark pink cap 0.2 ml/10mcg dose as a first and/or second dose).    Concomitant medication not reported.   Dosage text for suspect product was reported as unknown.  Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732802 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732802:Same report
This spontaneous report as received from a physician refers to a male patient of unknown age with a history of previous cancer who on an unspecified date was vaccinated a dose of ZOSTAVAX (lot #, dose and site of administration were not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient experienced shingles. No treatment was given for the adverse event. It was reported that the patient advised to his doctor. At the time of the report, the outcome of shingles was unknown. Additional information has been requested.
I experienced widespread herpes simplex infection over my face, genitalia, back and groin that needed 3 months prescription of Acyclovir. this is the 1st time I have widespread herpes simplex in my life and it was very severe. my CBC was normal and the doctor said this abrupt widespread herpes simplex is unknown. this herpes started few days after my booster of Pfizer. I first noticed multiple herpes on my lips then I on my fingers then on my genitalia. I then sought medical attention and the doctor prescribed Acyclovir.
Gagged, Choked, and stopped breathing. Cpr was administered. Discharge Summary received which stated patient experienced cyanosis and gastroesophageal reflux.
pt recv vax & exp severe redness, soreness & swelling in the arm & joint;MD reported 7 other pt exp similar rxn p/pneumococcal vax WAES 96102615;96110038;98060229-98060233;
Pt states she has constant pain at injection site that radiates down arm to her wrist. Extremely painful when pressure applied to that arm.
I21.4 ACUTE NON ST ELEVATION MI 3/27/2023 ACUTE NON ST ELEVATION MI I21.4 ACUTE NON ST ELEVATION MI 3/27/2023 ACUTE NON ST ELEVATION MI I21.4 ACUTE NON ST ELEVATION MI 3/27/2023 DM 2 W RENAL MANIFESTATION
Pregnant Participant was administered a flu shot of Afluria. There was no adverse reaction to the injection.
Case number PHEH2014US012232, is an initial spontaneous report received from a nurse on 16 Jun 2014, with a follow up received from nurse on 21 Jul 2014. This report refers to a 22 year old female patient. She received MENVEO (batch number: A11052), reconstituted with an expired Men A with MenCYW-135 liquid component intramuscularly at dose of 0.5 ml on 16 Jun 2014. She was revaccinated. The reporter explained that, she was not aware of any reports of adverse reactions due to the maladministration. Follow up received from nurse on 21 Jul 2014: updated patient demographics, dose of MENVEO and other clinically relevant information in the narrative.
Onset of rash, starting on the neck and upper trunk and then extending to the face and arms and legs and whole body.
Possible food allergy versus possible hives break up with MENACTRA (August 26th) -> hives 10 minutes after eating cheesy popcorn. BENADRYL - ORAPRED.
Erythemia and swelling L upper arm 7x10 cm; mild right arm flat 1x2 cm; 1 purple, 1 red papule.
No side effects noted until 10OCT90 @ 930am severe vomiting. Rushed to hospital & admited by MD, electrolytes IV, hospitalized 3 days.
Pt developed itching and a rash on her arm approximately 2 hours post vaccine.  colleague self medicated with Benadryl 7 hours post vaccine.  symptoms resolved and colleague reported to work the following day without issue
Day after patient had chills and body aches. When home and slept. Next day (10/6) those symptoms decreased. Rash with slight swelling around ADACEL injection site developed. Put some ice on arm for swelling.
Chest pain, headache, pounding heart with dizziness, swollen lymph nodes ( left armpit).
Approximately 2 hours afterwards?intense sweating  Later that evening?Nausea, body aches, fever, headache
Body aches; Fever; Fatigue; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male 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 03Apr2021 at 12:30 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included testosterone enanthate (XYOSTED) for an unknown indication  from an 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 04Apr2021, the patient experienced fever, body aches, fatigue and nausea. The patient did not receive any treatment for the events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, body aches, fatigue and nausea were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a physician via other manufacturer and described the occurrence of extensive swelling of vaccinated limb in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, fever, chills, pain in arm, radiating pain and swelling arm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, fever, chills and swelling arm were unknown and the outcome of the pain in arm and radiating pain were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, fever, chills, pain in arm, radiating pain and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The reporter was informed about the Pfizer Medical Information department. The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. The patient received vaccine on unknown arm. The patient experienced terrible reaction after receiving SHINGRIX. The patient experienced fever, chills, arms were swollen twice the normal size, the swelling went down to the elbow. The patient also experienced radiating pain down the arm that lasted for about a week. The nurse administered the vaccine properly. The patient asked if the same reaction would occur after receiving the 2nd dose of SHINGRIX and asked whether to receive the 2nd dose of SHINGRIX or not.
bullous pemphigoid; This case was reported by a consumer via call center representative and described the occurrence of bullous pemphigoid in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced bullous pemphigoid (serious criteria GSK medically significant). On an unknown date, the outcome of the bullous pemphigoid was unknown.   It was unknown if the reporter considered the bullous pemphigoid to be related to Shingrix.  Additional details were provide as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient experienced bullous pemphigoid since receiving the vaccine. The reporter wanted to know, what were the ingredients that caused this horrible disease to occurred.
Received flu vaccine and early afternoon developed bilateral hives to arms/back, shortness of breath, throat tightness. - (10-21-08) Took BENADRYL tablets she has at home and then came to health clinic at 9:30 PM the following day.
2 days, post vax, pt in ER. Pt had developed left arm pain, redness and impaired mobility. Partially recovered.
Headache, chills, achy, tired, soreness in arm, red circle around injection spot Took Tylenol and ibuprofen for headache
12/2 > ER at 12:19 PM with weakness difficulty walking, left & was back at 4:49 PM with worsening symptoms. Inability to walk without help, weakness all extremities, tingling hands, elevated BP 228/88. 12/4 unable to roll or move in bed by self, can raise arms slightly, 12/5 unable to swallow, aspirating, 12/7 able to move arms to head and raise knees off bed. Started Plasmaphoresis started 12/3 ended 12/9. Nasal tube placed for feedings and meds. CT & MRI of brain both negative. Spinal fluid negative culture.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild
Systemic: Headache-Severe, Additional Details: Patient experienced headache after receiving 4 vaccines. No relief with tylenol or ibuprofen even 2 days after vaccine. Patient to follow up with MD/emergency.
Information was received on 27 JUN 2002, from a registered nurse (infectious disease control nurse) and a physician concerning a male child who approximately three weeks ago (also reported as three weeks prior to onset of seizures) was vaccinated with a dose of varicella virus vacine live. On 18 JUN 2002, the child experienced status epilepticus and had a single vesicular lesion on his abdomen. That same day, he was admitted to the intensive care unit at the hospital. On 27 JUN 2002, the reporter stated that the child would be moved to a regular floor sometime today. It was reported on 28 JUN 2002 that the child had improved enough to be discharged from the ICU to a pediatric floor and he was being treated with intravenous antibiotics. An MRI was performed, with negative results. EEG results were pending, as of 28 JUN 2002. The physician was unsure of any lumbar puncture or results. Further information regarding medical history, concurrent conditions, medications, and treatment was not available at the time of the report. Additional information has been requested.
I received the hepatitis B vaccine on 1-21-2016. On 1-22-2016, a rash started to develop on my back & chest (both on left side.) It continued to spread & worsen. On 1-25-2016 my physician diagnosed it as shingles. I called to get lot number & expiration. Manufacturer is Merck. lot # L038018 exp 9-13-2017. It seems a strange coincidence that my shingles breakout began the day after my hepatitis B vaccination.
Client called on 11/13/07 to report symptoms of urticaria - raised edematous patches of skin with itching noted to (L) upper arm, radiating down back of arm 2 days post-flu vaccination. Did not have fever or other adverse reaction such as: breathing difficulties, wheezing or dizziness. Instructed client to take Benadryl and report to health unit when return to work on 11/14/07. Noted upon assessment, small "red bumps" to (L) upper arm - no swelling noted since using Benadryl within the last 24 hours. Itching resolved as well.
The above client had within 24 hours: Fatigue, lethargy, loss of appetite and general weakness.
Pt recvd 3 doses of Engerix-B 1OCT90, 1NOV90 & 13SEP91 & it was determined that pt did not seroconvert; 2NOV90 pt exp flu-like sx that lasted approx 24 hrs;
tenderness on the eve of vax in shoulder then following day noticd redness & swelling (size of mayonaise jar top) & fever & chills;t100.4, some nausea & dizziness;sx completely resolved 1wk p/starting;
This spontaneous report received from a registered nurse, via company representative, refers to a 13 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 13-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # L043214 (dose, frequency, expiry date were not reported), for prophylaxis, under Vaccine for children program (VFC). On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from  the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
pt given Adacel on 9-10-07. Next day experienced increasing amount of pain, redness and induration around injection site. When seen 3 days later area was 12 x8 " of erythema and 4" of induration.
Mental fog, cravings for sweet/bread, finding meats unappetizing unless they're salty. Paranoia (more than usual)that the vaccine is an immunocastration medication designed to lower my metabolism and cause me to eat less., and I am destined for a life of slavery because I was a bastard child, and by bastard child, I just mean that my father worked a lot, but and was falsely accused of abuse, even though I witnessed my mother instigate a fight by preventing him from sleeping, and threatening him with a knife by jabbing at his face.
Information has been received from a registered nurse referring to a 73 years old male patient. The patient had high cholesterol and was allergic to sulfa. Concomitant medication included atorvastatin, omega-3 marine triglycerides and aspirin (manufacturer unknown). On 24-AUG-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M005287 with expiration date 08-OCT-2017, 0.5 ml, intramuscular). On 26-AUG-2016, the patient called the physician's office to report redness and swelling in the right upper arm that the vaccine was administered in. The reporter stated that the patient was seen in the office on 26-AUG-2016 and was diagnosed with cellulitis of the right upper arm. Treatment was given for the event. No lab diagnostics studies were performed. The outcome of the event and the causality were not reported. Upon internal review, the event cellulitis was considered to be medically significant. Additional information has been requested.
Bivalent vaccine given to patient instead of primary series. This was to be the second dose of her primary series. 1st dose 1/20/22. Not immunocompromised.  Patient aware of error, no side effects or concerns exhibited.