chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided). On an unknown date, the patient suffered an unspecified adverse event. The outcome of the event is unknown. Causality was not assessed. Additional information has been requested.
Patient presented to the pharmacy on 10/19/17 with redness, swelling and warmth on left deltoid. Patient went to the ER for treatment.
She has a history of asthma, which has gotten worse since receiving the second dose of the vaccine; harder time breathing all the time since after the second dose/ has more difficulty breathing but it progressively got worsen; she cannot sleep / She could sleep fine and then would lose some sleep. Last night she only slept one hour and would have to sit up to breathe; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 18:00 (Lot number: FC3183) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: diagnosed about 25 years ago; "allergic to penicillin" (unspecified if ongoing), notes: diagnosed about 25 years ago. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for asthma (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Lot number: EW0181, Anatomical Location:Left upper arm, Time: 18:00), administration date: 28Jul2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: ASTHMA (non-serious) with onset Aug2021, outcome "not recovered", described as "She has a history of asthma, which has gotten worse since receiving the second dose of the vaccine"; DYSPNOEA (non-serious) with onset Aug2021, outcome "not recovered", described as "harder time breathing all the time since after the second dose/ has more difficulty breathing but it progressively got worsen"; INSOMNIA (non-serious) with onset Aug2021, outcome "not recovered", described as "she cannot sleep / She could sleep fine and then would lose some sleep. Last night she only slept one hour and would have to sit up to breathe".  Additional Information: Patient had not always had big issues with asthma, and it is not frequent, it very rare for her to have difficulty breathing. Vaccination facility type was pharmacy and was not administered at facility. There were no additional vaccines administered on same date of the Pfizer Suspect. There was no emergency room visit. It was reported that patient had only first dose prior to vaccinations within 4 weeks. There was no AE following prior vaccinations and also none relevant tests reported. She went to doctor to get refill of her albuterol inhaler. Concomitant Albuterol does not really help her as much. She was wondering how long the symptoms will last, if it will go away. She did not use it frequently and it was an expired prescription. She was initially prescribed it about 25 years ago.  No follow-up attempts are possible. No further information is expected.
redness around the injection spot, fever chills, Stomach Ache, Body Ache, Short of breath (walking up stairs ), Headaches  no appetite, Dry heating .
After the first moderna shot I had mild headache, slight nausea, slight dizziness, very mild, almost inconsequential; not only did those symptoms not clear up, they became exaggerated following the second shot which was February 13th 2021 at the same clinic; after the second shot I got quite sick for 3 days i.e. fever, chills, aches, etc. The problem is that the headache, dizziness, nausea, slight aches, neck ache, congestion has never cleared up and it's been almost two months since the last shot.
Myalgia Narrative:  Local mild soreness and mild general aches for 2 days.
chills; body aches at night/ body aches/ aches/ pain; cold; This is a spontaneous report from a contactable Registered Nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (lot number and expiry date unknown) for the first dose and on 08Jan2021 (lot number and expiry date unknown) for the second dose, both at a single dose for COVID-19 immunization. The patient's medical history included allergy to azithromycin and sulfa antibiotics; patient never had an allergic reaction to a vaccine. Concomitant medications were not reported. The patient previously took amoxicillin and had an allergy, she gets hives. The patient reported to have received the second dose of the vaccine last 08Jan2021 and experienced chills and body aches at night. She took Advil and Tylenol for it and it resolved with gradually decreasing symptoms over the week. Yesterday at work she got cold (pending clarification) and started experiencing body aches again. She took an Advil for it again. She reported that she did not have a fever at all. She is asking if this could be possibly related to the vaccine and how many days should the side effects last. She is also asked if she should get tested for COVID given the symptoms. The patient further reported that she was not having a fever, but she is still getting chills and aches. She said that she was not around anyone that has COVID and wears her mask when out. She asked if this could be from the vaccine. She said that she felt this way when she first got the vaccine as well. No fever, just body aches, pain, and chills like she can't get warm, and got cold (pending clarification). She takes Tylenol and Ibupriofen and she is fine, but she has to take them. Patient wanted to know if this is the vaccine working its way through her system. Does she need to get COVID tested? Is this from the Vaccine? The outcome of the events was unknown.  Information about lot/batch number has been requested.
Patient was administered more than the 0.5ml does of vaccine.  Patient experience, local swelling, erythema and tenderness at the injection site.  Patient seen in office 3 days after injection with local symptoms and no other systemic symptoms.
CLIENT RECEIVED 5 VACCINES; 3 IN THE LEFT UPPER ARM AND 2 IN THE RIGHT UPPER ARM. LA-SQ = VZV; LD = FLUCELVAX  IM AND HEP A PED 2ND DOSE IM. RIGHT ARM RECEIVED HEP B PED 3RD DOSE IM AND HPV9 2ND DOSE IM. APPROXIMATELY 1 DAY LATER THE CLIENT HAD REDNESS, INDURATION, SORENESS AND SWELLING TO THE LEFT UPPER ARM (PER THE MOTHER). THE CLIENT'S MOTHER, BROUGHT THE CLIENT BACK TO THE HEALTH DEPARTMENT ON 11/2/23. THE CIRCUMFERENCE OF THE LEFT ARM WAS 9.2 INCHES AND THE CIRCUMFERENCE OF THE RIGHT ARM WAS 8.5 INCHES.  THE REDNESS AND INCURATION ON THE LEFT ARM MEASURED 5.5 INCHES IN LENGTH AND 5 INCHES WIDE.  WE OBTAINED ADVICE FROM OUR SENIOR IMMUNIZATION NURSE AND RECOMMENDED ICE TO THE AREA. WE EXPLAINED THAT THIS REACTION WAS NOT AN ALLERGY NOR A CONTRAINDICATION TO FUTURE VACCINES. VS 107/66, PULSE 102, RESP 18, AFEBRILE, OXYGEN SATURATION WAS 99%. RECOMMENDED THE MOTHER TAKE HER SON TO A PHYSICIAN/ER IF SHE FELT FURTHER CARE WAS NECESSARY
19 Sep 10 Extremely fatigued at 1630; aching leg joints and muscles plus chills at 2000; nausea at 2100; vomiting/diarrhea from 2200 until 0600 20 Sep 10. 20 Sep 10 nausea and headaches most of the day; minimal po intake; 21 Sep 10 "chest on fire" at 2200 --> relieved by sitting upright.
canker sore under my tongue; This case was reported by a consumer and described the occurrence of tongue aphtha formation in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tongue aphtha formation. On an unknown date, the outcome of the tongue aphtha formation was unknown.   It was unknown if the reporter considered the tongue aphtha formation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and got a canker sore under my Tongue. The reporter asked was that a side effect.
Sudden onset of fatigue followed by body aches, chills, fever 102.5F, night sweats, headache
Rash on face, arms, legs, and back. Used Benadryl PO and hydrocortisone cream at home with relief. Sought med attention for assurance. Reviewed signs and symptoms of anaphylaxis and instructed to continue Benadryl PRN.
Injection site raised, very large, swollen, very red, painful, hot, and is approximately 7" across. Low grade fever, nausea, vomiting and diarrhea. Antibiotic, cool compresses and Benadryl.
Patient was reported to be deceased the morning after vaccination on 1/12/23. Unknown exact time of death during the night.
3/9/21 PM headache, 3/10/21 AM fever, generalized achiness, 3/11/21 bilateral hand swelling and rash on hands, diffuse itching.  3/14/21AM swelling around eyes.  continues itching.  continued fever.  swelling in hands improved.
like burning ice; 2 days after she got the injection, she started getting the same thing, same symptoms in her skin: She just tried everything: Cold, icy hot, all kinds of creams, and nothing helps. She has the feeling on her back, in the area where she had shingles.; sort of itchiness; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (like burning ice), HERPES ZOSTER (2 days after she got the injection, she started getting the same thing, same symptoms in her skin: She just tried everything: Cold, icy hot, all kinds of creams, and nothing helps. She has the feeling on her back, in the area where she had shingles.) and PRURITUS (sort of itchiness) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F211A, 047A21A and 036521A) for COVID-19 vaccination.     Previously administered products included for Prophylaxis: Flu Vaccine.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced BURNING SENSATION (like burning ice), HERPES ZOSTER (2 days after she got the injection, she started getting the same thing, same symptoms in her skin: She just tried everything: Cold, icy hot, all kinds of creams, and nothing helps. She has the feeling on her back, in the area where she had shingles.) and PRURITUS (sort of itchiness). At the time of the report, BURNING SENSATION (like burning ice), HERPES ZOSTER (2 days after she got the injection, she started getting the same thing, same symptoms in her skin: She just tried everything: Cold, icy hot, all kinds of creams, and nothing helps. She has the feeling on her back, in the area where she had shingles.) and PRURITUS (sort of itchiness) outcome was unknown.     No concomitant information was reported. The patient reported that after the first 2 doses but before the last booster dose, she had a flu vaccine, and she really felt her arm was very sore. She does not had any known allergies.She just tried everything: Cold, icy hot, all kinds of creams, and nothing helps. She has the feeling on her back, in the area where she had shingles. Caller stated she doesn't want to get more injections because that had gotten worse, and that was supposed to be half a dose.   This case was linked to MOD-2021-386895, MOD-2021-386572 (Patient Link).
Patient experience dizzy, light headed. patient was oriented3x. Patient was placed in supine position with elevated legs. Nurse took Vital signs were within normal range. EMS was called, pt left with ambulance.
Within days PT complained of headaches that become severe in intensity.  No history of migraines or other health issues . Just had a full workup prior for insurance purposes. Pt went to ER as pain would not subside and was sleeping a lot. Was diagnosed with a infarction in the brain x2. Headaches have never really improved and now is currently admitted into hospital with two more blood clots in brain.
Localized rxn to injection site. Warm to touch, red area, itchy.   Also reports throat swelling when received the vaccine but resolved with benedryl. No difficulty breathing.
Hives / itchy skin on body, tingling on head...Meds taken, Prednisone 50mg, Benadryl 25mg, Pepcid 40mg
It was reported that a 46 year old male pt was vaccinated with first dose of JE-VAX on Sept 03, 2002 (lot number EJN205B). Within 15 minutes after vaccination, pt developed a headache, and flu-like symptoms that lasted for about 5 days. Pt recovered.
Rapid heart rate/ he still feel a somewhat of rapid heartbeat; Shortness of breath; Chest pain; He felt nauseous; This is a spontaneous report from a contactable consumer (patient's mother reported for her son). A 13-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0168, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jul2021 10:35 (age at vaccination 13 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No investigation assessment. On Jul2021 the patient experienced rapid heart rate/ he still feel a somewhat of rapid heartbeat, shortness of breath, chest pain, he felt nauseous. Reporter stated, Patient had to go to the emergency room 23Jul2021 (yesterday) with rapid heart rate and shortness of breath and chest pain. So, she feels need to report this side effect or a reaction. And it was reported, it is important for young ones right and he still feel a somewhat of rapid heartbeat that's why it is important that anything he need to do, the doctors in the hospital said that if he continues, go back to the hospital but he has also an appointment with his doctor on Tuesday its just comes and go. Patient was not hospitalized; he was there in emergency room. Patient received treatment after the vaccine as Yes, Emergency room for rapid heart rate and shortness of breath. Motrin 400mg and Zofran for nausea because he felt nauseous. Regarding dose of, Zofran he don't know how much, he was looking for in papers but it does not say here. The outcome of event Rapid heart rate/ he still feel a somewhat of rapid heartbeat was not recovered, rest of all events outcome was unknown.  Follow-up attempts are completed. No further information is expected
I did not have an adverse reaction to the vaccine. I began not feeling well on 03/17/2023 and I tested positive for COVID-19 on 03/18/2023. I had a stuffy nose, headache and fatigue.  I contacted a provider and got a prescription for Paxlovid. I tolerated the medication without any complications. As of today, I continue to have congestion and cough.
About 8 days after the injection I developed a small red splotch around injection site. I continued to monitor and document it and the spot expanded. It is warm to the touch and mildly itchy. At this point there is a darker red border on the bottom.
Usual issues: Headache began about 2 hours after injection #1 moderna.  Dizziness began about 4-5 hours afterwards and lasted through the evening. Unusual issues: The day after receiving the vaccine she had several hand tremors,  and feeling as if she had several "mini seizures" throughout the day, a few longer staring spells, some twitches.  She felt "out-of it" all day.   She has petite mal seizures and a history of interictal epileptiforn discharges.  Also history of an intention tremor in her hands. (The mild tremors were primarily in her right hand, to a lesser extent the left).   Today, 2 days afterwards, today, so far, she feels better.   Yesterday was terrible, but we waited it out assuming it was injection related.
pt had severe pain and swelling at injection site, migraine so severe pt could feel her eyelashes when she blinked
Headache, body ache, lethargic.  Ended up falling asleep and sleeping for 13 hours.  Woke up to extrememly enlarge lymph nodes under left arm that continues 3 days after first seeing it.; Headache, body ache, lethargic.  Ended up falling asleep and sleeping for 13 hours.  Woke up to extrememly enlarge lymph nodes under left arm that continues 3 days after first seeing it.; Headache, body ache, lethargic.  Ended up falling asleep and sleeping for 13 hours.  Woke up to extrememly enlarge lymph nodes under left arm that continues 3 days after first seeing it.; Headache, body ache, lethargic.  Ended up falling asleep and sleeping for 13 hours.  Woke up to extrememly enlarge lymph nodes under left arm that continues 3 days after first seeing it.; Headache, body ache, lethargic.  Ended up falling asleep and sleeping for 13 hours.  Woke up to extrememly enlarge lymph nodes under left arm that continues 3 days after first seeing it.; This is a spontaneous report from a contactable other health care professional (patient). A 35-year-old male patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ek5730 expiration date not provided), intramuscular (arm left) first dose on 17Dec2020 13:00 at single dose for covid-19 immunisation. There were no medical history. The patient concomitant medication includes Multivitamin. On 01Jan2021, the patient experienced Headache, body ache, lethargic. Ended up falling asleep and sleeping for 13 hours. Woke up to extremely enlarge lymph nodes under left arm that continues 3 days after first seeing it. No treatment was given for the events. The outcome of the events was recovering. On 07Jan2021 01:15 the patient received second dose intramuscular (arm left) at single dose (lot number EL1283 and expiration date not provided) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). Facility where the most recent COVID-19 vaccine was administered in the Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination the patient did not tested positive for COVID-19. Also, patient did not test positive prior vaccination.
Dizziness, followed by brief syncope, all resolved within 2 minutes. She fell out of chair on to ground and immediately woke. Sweaty and pale, placed cool compress on back of neck and gave her a cold water to drink. She remained upright on the floor for approximately 5 minutes until she felt like she was fully recovered. Her father was present the entire time. She stated that she had no injuries or pain from falling out of chair. No rashes, bruising or bleeding observed. Mgr came over and patient's father declined to file a report for injury.
On 5/22/95 pt. recv. vax and laboratory evaluation on 3/1/96 revealed a lack of response.
This spontaneous report was received from a pharmacist refers to a female patients of unknown age. On an unknown date in the year 2013 (also reported as last year in spring or summer), the 2 patients were vaccinated with ZOSTAVAX (dose and frequency was not reported) intramuscular rather than subcutaneous. On an unknown date, the 2 patients experienced ZOSTAVAX injection hurt a lot and quite a bit. The outcome of the event ZOSTAVAX injection hurt a lot and quite a bit was reported as recovered. The reporter did not assessed the causality between the event and the suspect drug. Additional information has been requested.
increased left upper arm soreness; mild injection site pain; This is a spontaneous report from a non-contactable consumer.  A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 15:30 at single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient developed mild injection site pain that evening on 18Dec2020 and reported as increased left upper arm soreness on morning no limitation in movement on 19Dec2020. No other local/systemic events. Event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Initial and follow up information has been received from a mother concerning her son with a history of premature birth who on 08-OCT-2007 was vaccinated with MMR II (lot# 654443/0952F) (dose not reported). Subsequently the patient developed measles within 10 days of receiving the vaccine all over the body (head to toe). The patient still has scars and little raised bumps on his skin on his back, belly, and upper legs 6 months after the vaccination. It was reported that the patient was recovering from the measles. The patient sought unspecified medical attention by calling the physician's office. The mother indicated that she had "heard of other children that developed measles following vaccination with M-M-R" but had no information on other cases. This is one of two reports from the same source. Additional information has been requested.
This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age and ethnicity received PREVNAR 13 (Lot Number: J67646; Expiration Date: Mar2016), intramuscular on 02Feb2015 at 12:18 PM at 0.5 ml single dose in the left arm. The patient's medical history and concomitant medications were not reported. On 02Feb2015, the patient experienced redness and swelling in arm at the injection site. There was no treatment given for the events. The events did not require an emergency room visit or physician visit. The clinical outcome of the events, redness and swelling in arm at the injection site, was recovered on an unknown date in 2015. The pharmacist assessed the causality between the events, redness and swelling in arm at the injection site, and PREVNAR 13, as possibly related. Follow-up (21Jan2015): New information received from the same contactable pharmacist includes; patient demographics (gender), suspect product data, reaction data (onset of event), outcome (recovered), treatment (No), and causality (related). Follow-up attempts completed. No further information expected.
swollen lymph node; This spontaneous case was reported by a nurse and describes the occurrence of LYMPHADENOPATHY (swollen lymph node) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph node). At the time of the report, LYMPHADENOPATHY (swollen lymph node) outcome was unknown.        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 medical  provided by the reporter. No treatment information provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-089616 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089616: