chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a currently 60 year old female patient. On 29-JUN-2017 the patient was vaccinated with ZOSTAVAX for prophylaxis lot# N009777 exp 04-MAR-2018. The vaccine had been stored improperly at temperature of 6° Fahrenheit to 14° Fahrenheit for 10 minutes and then 15° Fahrenheit to 46 F° Fahrenheit for 30 minutes. No previous temperature excursion. Call was due to data logger. There were no adverse events. Follow up information has been received from the pharmacist on 28-AUG-2017. The reporter stated that on an unknown date, the patient was vaccinated with ZOSTAVAX and was reconstituted with a sterile diluent (manufacturer unknown). The reporter stated that minor issue of freezer and no adverse events. The reporter has no further information to report.
First day I was lightheaded, dizzy, sore all over, weak and had the chills. The second day i had severe chest pain and trouble breathing, I went to the ER and was admitted into the hospital because of this. After an EKG it was found that I had Myocarditis. To treat it they gave me an IV for the pain, then I was prescribed ibuprofen and 2 other meds for the inflammation around my heart.
pt recvd vax; devel low grade fever, sweating, flu like sxs;
pt recv vax 19AUG80 & 19AUG80 pt exp a febrile convuls;pt recovered from febrile convuls;
Patient was set-up to receive the COVID-19 Bivalent vaccine. Patient was interviewed as to when the last dose was and if they had had COVID within the last 90 days. Vaccine was administered and when the information was entered into database the pharmacist realized that the patient had already had the Bivalent vaccine on 9/21/22. Patient was called to inform him of what had happened and to report any major adverse events. None were reported.
PATIENT EXPERIENCED SLIGHT SYNCOPE, NAUSEA AND VOMITING AROUND 5 MINUTES AFTER INJECTION. PATIENT WAS GIVEN A WASTE BASKET, A WET PAPER TOWEL (FOR CLEANING OF THE MOUTH) AND A BOTTLE OF WATER AND WAS ASKED TO REMAIN IN THE VACCINATION BOOTH IN A CHAIR THAT HAD ARMS TO PREVENT FALLS AND POSSIBLE INJURY. PATIEN LEFT 15 MINUTES LATER UNDER OWN VOLITION WITH NO VISIBLE LASTING EFFECTS.
Blurred vision within 5 hours Fainted when getting up in the night to address eye concern
Day 2: chills and fever, aches and pain, tight throat Day 3-4: continued aches and pains throughout the body Day 5: sore under the arm, all the way up to the neck and left breast, and at administration site. Difficult to swallow.
Day of injection patient started to have pain in that left arm after injection. It was not severe or worrisome. Next day, 24 hours later started developing tenderness. 2 days after the injection, Saturday 09/29/2018 she took a shower in the early morning and noticed the redness of the L upper arm approximately 3 inches away from the injection site and continues across to the inside of the upper left arm and tracks to the under arm pit region. She presented back to the pharmacy. This pharmacist noticed the redness was warm to touch and tender. Referred to urgent care or other medical clinic for attention as it gives the appearance of cellulitis. Which is not originating from the injection site but in that same arm.
strange feeling and some pain began on left side of neck, left ear and went up my whole neck to my face.  Unsure what the feeling was then realized it felt numb and swollen. tongue felt thick. kinda of like after being numb at dentist office. I also felt kind of tired. I was afraid my throat was going to close up but it didn't.  after 1 hour the feeling began to fade. and then went away.
Spouse states 1 day after taking 1st oral typhoid capsule, she developed nausea, headache, abdominal cramps, forgetfulness, disorientation, wheezing. She continued capsules until complete.
severe pain at the upper right arm /sore arm; sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain at the upper right arm /sore arm) and SOMNOLENCE (sleepiness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (severe pain at the upper right arm /sore arm) and SOMNOLENCE (sleepiness). At the time of the report, PAIN IN EXTREMITY (severe pain at the upper right arm /sore arm) and SOMNOLENCE (sleepiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt at clinic for well child check, no complaints for exam. At 15 minutes following administration of HPV, pt c/o headache, bilateral leg pain and had tremors of hands and feet. Was given TYLENOL PO, water and started on O2. O2 saturation dropped briefly to low 80s and was then undetectable by machine. Pt remained breathing; EMS called. Pt stable on RAM air with EMS/ER. Seen by GI specialist 5/2 and doing well.
Severe vision blurriness. Unable to distinguished a red light from a green light. It went away 24 hours later.
Fever and body aches for 5 hours even after taking Aleeve. Fever peaked at 100.3
Left arm began to have pain and muscle soreness within hours. Left arm began experiencing muscle twitches. Arm became so painful I could not lift it around 5 hours after the injection. By 2:00 AM (12 hours after injection) I experienced flu-like symptoms (aches, pains all over body), my left arm was so painful I took pain relievers to help me sleep. At 24 hours after the injection my body is aching and sore all over with significant pain in my joints. Arm is still painful, even with the slightest movement or touch.
A report was received from a health care professional on 08Nov02, concerning a female vaccinee who inadvertently received Fluvirin SC on 07Nov02. On 07Nov02 the vaccinee received 0.5ml Fluvirin SC. No adverse reaction was reported in relation to the incident. There was insufficient information to determine the reporter's causality assessment. Cross reference with: PJP200200731, PJP200200690, PJP200200728, PJP200200743, PJP200200729, PJP200200742, PJP200200741, PJP200200720.
High Fever, Swollen Lymph Nodes in Neck nearest injection site, extreme irritability, fatigue, weakness, rash.
196 patients received 0.25mL of Moderna COVID-19; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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 an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19) 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 UNDERDOSE (196 patients received 0.25mL of Moderna COVID-19).    It was unknown if received any other vaccines 4 weeks prior to COVID-19 vaccine.  No concomitant medication reported. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow-up document received on 27-Dec-2022 with Reporter details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:Master case
Patient experienced a very painful arm, followed by tingling and numbness that traveled down arm and into hand
Eleven days after injection, raised, red, hot, painful lesion appeared on left arm about 2" from injection site. Over the next two days, a rash spread to cover most of the upper arm, but was only itchy. After five more days (16 days after injection), center of initial lesion began to turn normal skin color.  Skin color back to normal after four more days (20 days after injection). No fever, no aches, but more fatigue than usual and some diarrhea.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot #, expiration date, site and doses were not reported). It was reported that the vaccine was exposed to temperatures ranging from 29 Fahrenheit degrees (F) to 35 F for cumulative time frame of 16 hours before administration to the patients. No previous temperature excursion was reported. Digital Data Logger was not involved. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Did not receive the Second dose after 35 days; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive the Second dose after 35 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive the Second dose after 35 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive the Second dose after 35 days) 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 medications were not reported. Treatment information not provided.
Patient came in to receive the Pfizer bivalent booster dose for 6-11 y/o. Patient received the regular PPfizer bovalent 12+ dose. I have followed up with mom today 11/6/22 and her daughter does not have any symptoms or side effects.
My left arm below the injection site got very red and felt hot to the touch.  The redness spread down to the elbow and my upper arm was swollen. I had experienced these symptoms previously with injections and it was the weekend, so I did not see a doctor and the  redness started to fade after three days.  This happens to me now each time I get a shot.  The worst was a Tetanus shot where my arm was red, swollen, and very hard to the touch and it stayed that way for over a week.  My physician feels I may be allergic to the preservatives in injections.  She wants me to get a Shingles shot because of my age and I am very worried about getting one.
Extreme Exhaustion followng day - could not left head from pillow - did not eat for 3 days - appitiete has returned - But am left with deep fatigue for over 2 weeks - Friday, March 26th will be 3 weeks - leg still week - fatigue  - is this normal what can I do - Too weak to drive to see doctor - Last week he said - do what you can and take Tylenol - First dose same reaction for 2 weeks - but was fine for second dose  - Now I am going into 3 weeks with fatigue.  Is this normal - I did have the virus in April - had antibodies but did not have this reaction after.  Please will this cease?  Acknowledge ASAP
Report A0370072A described a rash in a 26 y.o. male subject who received Hep B vaccine recombinant (Engerix-B). Medical history, concurrent conditions, and concurrent medications were not provided. On 5/23/02, the subject received his 2nd injection of Engerix-B (lot # ENG5252A2). Immediately following the injection, the subject experienced an inject site reaction characterized by swelling. Later that evening, the subject experienced a "heat-like rash" on his upper body after he played a game of basketball. The inject site swelling was treated with ice and most of it resolved w/in 20 mins. Treatment for the rash was not specified but it reportedly resolved w/in 3-4 hrs. By 5/24/02, the inject site reaction of swelling had completely resolved. The physician advised the subject to contact the student health physician regarding this info. Additionally, the physician recommended that the subject receive his next injection at a "medical facility that has access to emergency facilities." on 9/17/02, the reporting nurse considered only the inject site swelling to be related to Engerix-B administration.
Headache - continuous; extreme fatigue; unable to conduct normal daily activities; some coughing, runny nose
I got th eJassen COVID-19 Vaccine EUA at 10:50am. When the needle was removed, blood ran down my arm. That has never happened, but it might have been the nurse. I had nausea for a few minutes afterwards, but I think that was due to the blood. I didn't feel like eating after the shot. Hours later, around 5pm or so, I started to feel hypersensitive and weak. I also started to have a fever that went up to 102.2 farenheit before decided to take ibuprofen.  I had shakes, a heartbeat of 146, and a headache. It lasted all through the night and into the next day. Around 11:20am, whenever I moved my head, I would feel pain in my head. By the end of this day, I started to feel more like myself. By the start of the third day, all I had was pain in my left arm from the shot. It was strange that the pain got worse from Day 1 to Day 3, but that might be from how the vaccine was given and the blood that ran down my arm at that time. Another thing is my appetite has gone down a lot. I don't want to eat and when I do, I just want to stop. It's been a couple days, so I'm hoping my appetite will come back.
Initially first 3 days sore left arm. A week later from injection, extreme itching in arm for 1 week.  Scab developed over vaccination area.
Cough began at 5:00, 6:00, very tired, nausea, dry heaves, chills, sweats, fever, mild diarrhea, lasted approx 4 hours
I had the expected injection site pain and aching arm for 6 full days. By the end of the seventh day, I was back to normal. However, on 3/27, 12 days after the injection, I had sharp, intense, pin-pointed pain at the injection site for most of the day. The following two days, (3/28 and 3/29) I did not have pinpointed injection site pain anymore, but my whole right arm aches. These are all expected effects, but they have lasted longer than expected, as it has now been a full two weeks since my injection and I was told to expect symptoms for up to a week.
"Patient was given their first COVID-19 vaccine dose. Patient was given VIS sheet and informed of all potential side effects and when to seek emergent care.  Patient was given a follow-up plan and scheduled for administration of second dose.  Patient tolerated procedure well. At 15 minutes post vaccine 1147 patient reports that she had just experienced chest pain sharp on left side of chest followed by nausea and slight sensation of tightness in her throat. She reports this lasted about 30 seconds and then subsided and went away. Vitals taken BP 118/76 HR 66 R 16 pulse ox 100% on room air. Patient denies any cardiac history and no history of allergic reaction in past to any medications or injections. Vaccine was given in right deltoid. She was monitored an additional 15 minutes with during which time she was asymptomatic. I consulted with ARNP provider across the hall in care clinic prior to letting patient leave clinic and she was agreeable with plan of care. Patient was advised is symptoms chest pain, tightness in chest, any shortness of breath she needs to seek emergent care by calling 911. She communicated understanding. Patient discharged to home."
This spontaneous report as received from a physician's assistant refers to a 23 year old female patient. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 06-JUN-2017, the patient was vaccinated on an unspecified arm with GARDASIL 9 dose 2, lot # N001533 (expiry date, dosing details, route were unknown) for prophylaxis. The reported stated that the patient was seen in the office on 23-JUN-2017 and her arm was swollen and painful at the injection site; and the patient complained of the pain when she moved her arm. The patient's arm had "a 5 and 1/2 elevation". The outcome of the events was unknown. There were no product quality complaints (PQC) involved. The causality was not reported. Additional information has been requested.
Swollen hands, itching all over (hives); Given DPH 9APR91 rash still present;
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he tested positive with Covid-19 and he is fully vaccinated". The patient underwent the following laboratory tests and procedures: COVID-19: Positive, notes: he tested positive with Covid-19 and he is fully vaccinated. Clinical information: Patient just started taking Paxlovid and mentioned that he tested positive with Covid-19 and he was fully vaccinated. He mentioned that he knows that Paxlovid can cause liver damage and he was asking when he can start drinking alcohol after taking Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This is a spontaneous report from a contactable nurse who reported 10 cases for different patients. This is the 9th of 10 cases. A 65-year-old female patient of an unspecified ethnicity received PREVNAR 13 , via an unspecified route of administration on 27Jan2017 at 0.5 ml, single  Lot S15227 Expiry Date 01Feb2018 in Deltoid Left, for immunisation and  influenza vaccine  via an unspecified route of administration on 27Jan2017 at 1 DF single in Arm Right, for immunisation.  Medical history included hypertension from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported.  The patient experienced fever chills, swelling at the injection site  on an unspecified date with outcome of unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017083713 same reporter/drug, different patient and event.
No adverse event; dose was administered 2 days after the vial expiration date on 2/14/23; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was administered 2 days after the vial expiration date on 2/14/23) and NO ADVERSE EVENT (No adverse event) in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was administered 2 days after the vial expiration date on 2/14/23). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was administered 2 days after the vial expiration date on 2/14/23) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (dose was administered 2 days after the vial expiration date on 2/14/23).    Concomitant medication was not reported. Treatment drug was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-710657 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710657:Patient 1 out of 2
Left Thigh has small non painful, not red bump at injection site. No fever, no other concerns.
Blotchy erythematous patches coalescing over injection site, forming 12 cm slightly raised erythematous plaque.
Two- three minutes after shot I sat down and I could feel liquid streaming from my stomach and traveling to the top of my head.  I began to get so dizzy that I thought i would die. Lasted in all about  four minutes.  Informed workers after my fifteen minute wait and was told it was probably ? shot anxiety.?  What happened to my body was exactly like my ruptured brain aneurysm except I did not feel a cracking sound in my brain.  Very scary experience.
Parent report that about 1week after receiving Varivax & DTaP, the child had a very abrupt behavioral change, which reverted just as abruptly about 1 week later. Has not reoccured, Spells of inconsolable screaming, head banging, not making eye contact, poor sleep, intense irritablity, Not reported until this date- has been apparently fine for the past 2weeks.
Information has been received from a 71-year-old female consumer with a history of breast cancer with radiation about 8 years ago and "previously in her 50's had developed the shingles and eventually had recovered" who in April 2007, was vaccinated with a "single dose series" of zoster vaccine live (Oka/Merck). Concomitant therapy included vitamins (unspecified) and "abalide." On 18-FEB-2008, the patient noticed that she started to have pain in her right shoulder. The consumer reported that later on that night she noticed she had developed the shingles again which were located on her right side on the upper body around her breast area and her upper back. The consumer reported that her shingles did not have any puss sores, but she had pain. She did see a physician who gave her medication to treat the shingles. There were no laboratory tests performed. The consumer reported that the shingles have faded, but she still can see some of the lesions, and that her pain that she had associated with the shingles first went away in the front and then around 02-Apr-2008, the pain on her back had gone away. No product quality complaint was involved. Additional information has been requested.
pt was under the age of 18 when received the vaccine the only AE she had is sour arm
The patient reported tingling up his arm after I gave the shot. He stated it may have all "been in his head" but he stated his arm was tingling. He felt this throughout most of his arm per patient.
So that night throughout I felt feverish around 100.9 the highest was 101F. I would break though and then 1-2 hours later again it would come back. Body chest, couldn't move my arm, the pain was severe. Tuesday I could not even sit down I felt so weak, I had rashes in my face, legs, chest. I was so weak, I fainted and hit my head twice while going to the bathroom and kitchen. I felt like I was constipated, ant then I had diarrhea, I did not have appetite but could not hold anything in, I would throw up. My left side was all numb. I could not feel anything. It was like that the while Tuesday. Wednesday body aches, rashes, numbness, but I had a little bit of a body strength and could walk on my own. Thursday I was able to start eating a little bit and constipation were stating to go way. Friday was just body aches.  Sunday the rashes finally went away.
Flushing/sweating, anxiety. BPs 150/98 (pulse 118), 141/85 (pulse 98). O2 sats 97%, 98%. Rested and drank water.