chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heartburn; Indigestion, acidity; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), DYSPEPSIA (Heartburn) and DYSPEPSIA (Indigestion, acidity) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced PAIN (Body aches), DYSPEPSIA (Heartburn) and DYSPEPSIA (Indigestion, acidity). At the time of the report, PAIN (Body aches), DYSPEPSIA (Heartburn) and DYSPEPSIA (Indigestion, acidity) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Patient presented to clinic and stated he wanted Pfizer vaccine. The nurse thought it was acceptable to mix and match brands of vaccine. All staff personnel were reminded that the primary series must be the same brand. Mixing is only for booster doses.
small nodule above my clavical on the left side; swollen lymph node; tenderness; tired after second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Lot number: EW0158) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]. Vaccination history included: Bnt162b2 (dose 1), administration date: 25Mar2021, for Covid-19 Immunization, reaction(s): "tired". The following information was reported: NODULE (non-serious) with onset 14Apr2021, outcome "unknown", described as "small nodule above my clavical on the left side"; LYMPHADENOPATHY (non-serious) with onset 14Apr2021, outcome "not recovered", described as "swollen lymph node"; TENDERNESS (non-serious) with onset 14Apr2021, outcome "not recovered", described as "tenderness"; FATIGUE (non-serious) with onset 14Apr2021, outcome "not recovered", described as "tired after second dose".  Additional information: The patient received her second dose at 1040 yesterday.  Her first dose was fine, she was just tired. Today she was fine in the morning, she was is a little tired now, she seems to have a swollen lymph node like up on her neck, right above her clavicle. She noticed it was a side effect and is asking if it is temporary. She felt tenderness, felt a nodule. She got tired today at 1230.  That was the primary symptom the first day after the first dose also.  It was not so much that she couldn't function, she was just tired. She laid down and thought why is her neck sore?  She touched the area and felt the nodule. This was 1230-100pm this afternoon about 25-26 hours after the second shot.  It's not worse or better. History of all previous immunization with the Pfizer vaccine considered as suspect was None.  Additional Vaccines Administered on same date of the Pfizer suspect was reported as no.  No follow-up attempts are possible. No further information is expected.
Patient reported muscle pain in left arm beginning from shoulder extending to lower arm soon after receiving 3 vaccines (ZOSTAVAX, BOOSTRIX, and PREVNAR) on 12/13/16. Patient received both ZOSTAVAX and BOOSTRIX in left arm on the same day. She reported the arm pain to PCP, but pain did not resolve after taking muscle relaxers and pain killers. Patient was still in continuous pain as of 1/18/17 when patient reported adverse reaction to pharmacy.
Tachycardia from 140-189 for 10 hours. Shortness of breath
after 4 hours felt as though I was collapsing; 24 hours after Moderna covid vaccine, 2nd dose the inoculation site became extremely swollen and very red....I could not move my arm.    It is now 72 hours after injection and I can barely get out of bed....I cannot pursue normal activities.     I am nauseous all the time, a terrible upset stomach with multiple bowel movements.    After 48 hours I have developed a bronchial cough when reclining..     I am dizzy, lightheaded, achy, overall feeling a malisse.      However, I can move my arm although it remains red and swollen.....but redness is not as severe.
The patient presented to the ER complained of rash, pain, swelling to lower extremities bilaterally. She had developed a maculopapular rash after the vaccination. She was discharged home on Percoat/Prednisone. Chills and unable to walk.
Redness, swelling, induration noted on left arm the next morning per mother, Apply ice give Benadryl, Augmentin as directed per Dr. Watch closely. Return as needed if no improvement or if gets worse.
Left upper arm and left shoulder became extremely painful with slightest movement and to touch. Body became chilled and energy level dropped dramatically for about 36 hours.  The movement of left arm was painful to the point of not able to use left arm or being able to touch upper left arm especially injection site.
pt recvd vax; screamed & cried for 6 hrs; fever of 101.9; seen in er by MD on call;
4-11-06 presented to Dr's office c/o L arm erythematous warm area over lateral arm extending to elbow and to axilla. No area of induration, no fever. DX with cellulitis RX'd with Keflex. Returned to office x 2 resolved cellulitis.
Mom called today, 10/19/2023, stating that patient has rash near immunization injection sites on bilateral upper arms. Patient seen in clinic on Monday, 10/16 and received Tdap in left deltoid and HPV #1 in right deltoid. Mom noticed rash last night 10/18/2023. Gave patient Benadryl at bedtime which seemed to help. This morning mom gave Claritin. Patient went to nurses office today as arms were itching. School applied hydrocortisone cream and he went back to class.   Rash is small, raised on left upper arm where Tdap was given (size of a needle per mom) and there are a few on right upper arm near HPV site. There are not as many on the right arm. Warm to touch but not swollen. Mom states they start on shoulder near injection site and go down about 5 inches. They are itchy.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 4/8/2021 and 4/29/2021. Presented to ED on 10/1/2021 with low blood sugar (25 per EMS arrival and 31 on arrival), generalized weakness, and a decreased appetite. Around 7AM son tried to wake her up but she was unresponsive prompting EMS activation. Patient reports weakness for about two weeks, cough for approximately one week with diarrhea. Patient completed 5 days of Remdesivir, also treated with Dexamethasone.  Patient required intubation on 10/8. Patient progressed to shock, A-fib with RVR, COVID, and possible UTI and maxed out on three pressors.  Family requested to switch to comfort care. Patient expired on 10/8/2021 with cause of death documented in chart as Septic shock with MOD & acute hypoxic respiratory failure 2/2 Covid PNA.
shingles; Information has been received regarding a case in litigation of a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  In 2014, the patient the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (dose, route of administration, lot number and expiration date were not reported).  Subsequently to the patient zoster vaccine live (ZOSTAVAX)inoculation, on an unknown date, the patient was treated for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The causal assessment was related.
Mother reporting pt. "started drooling and eyes rolled back in her head" while at the Mall approx. 1/2 hr after receiving the MMR vaccine.  Episode lasted approx. 2 min.  Pt. then acting lethargic and laying in Mother's arms. Mom called 9-1-1 and Paramedics evaluated pt. and then left as pt's eye were open and they felt she simply "passed out". Mom spoke with this Pediatric office who recommended pt. be seen at  Hospital. Mom called the Paramedics back who transported pt. to the ER where she was evaluated. Upon evaluation pt. was dx with probable post tonic-clonic seizure. To f/u with Neurology and schedule EEG.
Feeling lightheaded and anxious; vitals obtained/ stable, po hydration, rest, monitor x 30 minutes symptoms improve/ feels better released from facility w/parent (mom)
Left arm hurt; Diarrhea; Nausea; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Left arm hurt), DIARRHOEA (Diarrhea), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced LIMB DISCOMFORT (Left arm hurt), DIARRHOEA (Diarrhea), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever). On 09-Apr-2021, LIMB DISCOMFORT (Left arm hurt), DIARRHOEA (Diarrhea), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment details were provided by reporter.   This case was linked to MOD-2021-311111 (Patient Link).
lives in a 55 and older community and a lot of older people around her are having the same issue after having received the COVID-19 vaccines.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (lives in a 55 and older community and a lot of older people around her are having the same issue after having received the COVID-19 vaccines.) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (lives in a 55 and older community and a lot of older people around her are having the same issue after having received the COVID-19 vaccines.). At the time of the report, IMMUNISATION REACTION (lives in a 55 and older community and a lot of older people around her are having the same issue after having received the COVID-19 vaccines.) outcome was unknown.            Concomitant medication not reported.  The dosage text was reported as unknown. It was reported that the patient was not sure if all these other people have received the Moderna COVID-19 vaccine or not. Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-744892 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744892:Invalid case for Different patients
Invalid dose : 1cc was left during the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Invalid dose : 1cc was left during the vaccination) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported).   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced UNDERDOSE (Invalid dose : 1cc was left during the vaccination). At the time of the report, UNDERDOSE (Invalid dose : 1cc was left during the vaccination) had resolved.            No concomitant medicines were reported. No treatment information were reported.  Action taken with the drug in response to events was not applicable.
15 minutes after administration, a localized allergic reaction was noted. Injection site was red, raised and warm to the touch. Redness measures 3cm x 4cm. Dr. ordered Diphenhydramine 12.5mg to be given orally to pt. Patient was kept for 30 more minutes of observation. Redness was dissipating with no other change noted to the site. Patient was asymptomatic for any respiratory distress.
pt recvd vax  for insect bite? puncture wound? was walking barefoot; seen in ER; pain & swelling at L upper arm; again on 18sep94 w/ mental confus & L O C;
a few hours after receiving vaccine pt. had to go to ER with hives, difficulty swallowing, cough and chest pain and her chest, ears and throat itched
One day after having rec'd both Flu and Pneumonia vaccines in the same arm, patient's arm became painful (9/10). The following day, a red rash developed. Two days after having rec'd the vaccines, patient was prescribed Prednisone and Cephalexin. Two days later, pain and rash cleared fully.
I received the Moderna Spikevax 12+. I received on the 28th, around 4pm, by evening, the area was swollen, and hot to touch, and about the size of the entire deltoid. Hurt all night and sore. It continued for 24  hours with the red. An area of erythema with a diameter of 3 inches and enlarged with intermit series of feeling like bee stings in different areas on my upper arm, and itching over the entire area of redness, as well as above and below to the elbow. Have continued 96 hours post injection. It's sore, warm, and itching. Have taken oral pain relievers such as tylenol or nsaid, as well as applying the past 96 hours either hydrocor diclofenac gel.  Continued to be warm, swollen, and redness. Last night I have taken pictures for the past 3 days, it was 3 inches in diameter, redness around injection site was. Injection site left red papula of a sore, about the size a marker pen would leave on my arm.
chills; tiredness; headache; muscle pain; joint pain; my stomach was flipping but not nauseas; This is a spontaneous report from a contactable consumer (the patient).     A 81-years-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 12Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  Medical history included arthritis. On 22Mar2021 the patient received the first dose of BNT162B2 vaccine and experienced chills.  Concomitant medications included influenza vaccine (INFLUENZA VACCINE) taken for an unspecified indication, start and stop date were not reported.  The patient experienced chills  on 12Apr2021 with outcome of recovered , tiredness  on 12Apr2021 with outcome of recovered , headache  on 12Apr2021 with outcome of recovered , muscle pain on 12Apr2021 with outcome of recovered , joint pain on 12Apr2021 with outcome of recovered , my stomach was flipping but not nauseas  on 12Apr2021 with outcome of recovered. All the reported events were considered non serious.   Therapeutic measures were taken as a result of muscle pain and joint pain included Tylenol  Course of the event according to the patient. With the first shot I got chills four hours after shot on the same day, I had the chills for about three days. . But the second shot, the day of the second shot was 12Apr2021, I had the chills, tiredness, headache, muscle pain, joint pain and my stomach was flipping but not nauseas and I didn't had any swelling with that, I did came down with all those symptoms. I lasted for 1 week. I took Tylenol for pain. I have no such condition now, yes it did help. It wasn't a miracle but it did, you know it did help me to relax and sleep.  Information on lot /batch number has been requested.
The first couple of days prior to 11/19/2021-  I felt like I had pulled  a muscle in my back. I could not remember doing anything to have caused it. Any position I was in  I could feel like a pulling sensation. Where the pulling sensation was at that is were the rash started. 4 weeks post vaccine,  on 11/19/2021,  I just felt like I was dragging. Something just felt off. The next day,  I felt a picking sensation on the right side of my body and I realized there was the rash on the right side of my trunk.  The shingles were on the right side of my trunk of my body. The same side as  the vaccination. As soon as I got the rash, I called the doctor by teleconference and I showed him pictures of the rash  and  he diagnosed me with Shingles. The doctor prescribed an acyclovir ointment 5 % every day, Acyclovir in a pill form, 3 times a day for 10 days.  12/06/2021- The shingles are in the process of drying up. It's mostly troublesome at night.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 57-year-old male patient who received SHINGRIX (batch number DD43M, expiry date 7th March 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of herpes zoster (1st dose received on 31st July 2018, batch number 95LX9, expiry date 22nd February 2021). Concomitant products included SHINGRIX. On 11th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 11th October 2018, less than a day after receiving SHINGRIX, the patient experienced fever and pain in arm. On 12th October 2018, the patient experienced rash. The patient was treated with ibuprofen. On an unknown date, the outcome of the fever and pain in arm were unknown and the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the fever, pain in arm and rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced 2nd dose of SHINGRIX on left deltoid. On the same day that the patient received the 2nd dose of SHINGRIX, the patient experienced soreness in his left arm and a fever. The patient called the pharmacy on the reporting date and reported that 1 day after receiving SHINGRIX, he had a rash on his right glut that looked and felt like the previous shingles rash that he had. The patient noticed the rash when he woke up on the morning of reporting day. Patient described the rash as the size of a half dollar.
Approximately 2hrs. after receiving her 2nd HBV and a PPD she broke out in an itchy rash on her face, arms, and front torso...confluent, papular, dry, with some hive-like raised areas. She has no history of any allergic reactions and was well on the day of the vaccinations. PPd was positive in 2 days...referred to PHD for followup.
Arm pain; swollen lymph node in the left armpit with pain; +38 C fever.
PATIENT RECEIVED HALF DOSE (0.25 ML); This spontaneous report received from a health care professional concerned a 63 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 18-FEB-2023) .25 ml, administered on 14-DEC-2021 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 63 years old. No concomitant medications were reported. On 14-DEC-2021, the patient experienced patient received half dose (0.25 ml). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient received half dose (0.25 ml) was not reported. This report was non-serious. This case, involving the same patient is linked. This case, from the same reporter is linked.
I received my second Covid19 vaccine about 9:30AM Friday April 16, 2021. The next day, Saturday, I was on bed all day - exhausted.  I didn't eat or get up. On Sunday, I was still fatigued and had some vomiting and diahrea.  I was again in bed all day. Monday: fatigued and unable to get up and going. Tuesday: same - for the entire week.  After a week's time, I was still fatigued and began having a low grade fever. This situation lasted for TWO WEEKS. At the 14th day after my second vaccine, I went to the clinic and got urine and blood tests because I thought something was wrong with me.  All came back negative. The next day ( again, TWO WEEKS after the second shot), I finally felt better.
Patient brought to the ED by EMS on 10/30 for evaluation of shortness of breath. At her living facility, she was found to have a fever and agonal breathing. En route, the patient was found to have O2 sat of 90 on room air so was placed on 4L O2. In the ED, she tested positive for COVID-19 by PCR. Patient was admitted 10/30 - 11/6. She was diagnosed with sepsis secondary to COIVD pneumonia. Patient was discharged to skilled nursing facility with hospice care. She has received the COVID primary vaccine series and one booster.
This spontaneous report as received from the consumer's husband refers to a 65 year old female patient. There was no pertinent medical history and no drug reactions or allergies. On 16-OCT-2013, the patient was vaccinated with ZOSTAVAX (lot and dose not reported), subcutaneous. There was no concomitant medication. On 16-OCT-2013, the patient developed a small rash at the injection site. The rash was not painful. The patient sought for medical attention (spoke to pharmacist). No lab diagnostics performed. TYLENOL was given as treatment for the event. The outcome of small rash at the injection site was reported as not recovered. Additional information is not expected.
More than 35 days after the first dose without receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days after the first dose without receiving the second dose) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days after the first dose without receiving the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days after the first dose without receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment history was reported.
Red face with round, splotchy spots, were itchy: red itchy bumps all over back, neck. Ears bright red and swollen. Symptoms began within 2 hours of shots. Mom reports similar reaction with DTaP as baby. BENADRYL 25mgs every 6 hours for 24 hours.
Aching pain and stiffness in left arm, spread further down arm to elbow, left shoulder in back and moving into chest area to top of left breast and neck on left side.  Swelling was noticed on Aug 28, 2021 about 9am in all stiff areas.  Used heat massager; no help